FIXATION HARNESS FOR FACIAL MASK MANUFACTURED BY VYGON S A

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FIXATION HARNESS FOR FACIAL MASK

Request for Information Form	Contact Information
Company Name	VYGON S A
Address	5-11 RUE ADELINE
City, State, Zip	ECOUEN 95440,
Country	FR
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	AN - Anesthesiology
FDA Product Code	BTK
FDA Classification Name	STRAP, HEAD, GAS MASK
FDA Device Classification Code	General Controls
FDA Regulation Number	868.5560
FDA Common Generic Name	FIXATION HARNESS
FDA Proprietary Device Name	FIXATION HARNESS FOR FACIAL MASK
FDA Owner / Operator Number	8020785
FDA Owner / Operator Name	VYGON S A
FDA Establishment Registration Number	8020785
FDA Registered Establishment Name	VYGON S A
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-16-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of VYGON S A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AC HEALTHCARE SUPPLY, INC. 116-51 230TH ST. CAMBRIA HEIGHTS, NY 11411 US 905-448-4706 / 516-448-4706	AC HEALTHCARE	GAS MASK HEAD STRAP
2	AC HEALTHCARE SUPPLY, INC. 116-51 230TH ST. CAMBRIA HEIGHTS, NY 11411 US 905-448-4706 / 905-448-4706	AC HEALTHCARE	GAS MASK HEAD STRAP
3	ADVANCED CIRCULATORY SYSTEMS, INC. 7615 GOLDEN TRIANGLE DR. SUITE A EDEN PRAIRIE, MN 55344 US 952-947-9590 / 952-947-9550	RESQSTRAP	GAS MASK HEAD STRAP
4	AMBU INC. 6740 BAYMEADOW DR. GLEN BURNIE, MD 21060 US 457-225-2210 / 410-768-6464 1136	AMBU HEAD STRAP	HEAD STRAP
5	AMBU LTD. UNIT AB,3/F,NO.C, WAREHOUSE 7 PROCESS COMPLEX BUILDING XIANG YU F.T.Z., XIAMEN, CH 457-225-2210 / 45-722-52210	AMBU HEAD STRAP	HEAT STRAP
6	APOTHECARY PRODUCTS, INC. 11750 12TH AVE. SOUTH BURNSVILLE, MN 55337 US 800-328-2742 / 952-808-8324	HOT/COLD EYE MASK/SLEEP MASK	STRAP, HEAD, GAS MASK
7	AVALONAIRE INC. 907 LENAPE RD. WEST CHESTER, PA 19382 US 800-647-0172 / 800-647-0172	AVALONAIR HEADGEAR	CPAP HEADGEAR / CHIN STRAPS
8	BESMED HEALTH BUSINESS CORP. NO. 2, LN. 106, WU-KONG 3RD. WU-KUNG INDUSTRIAL PARK TAIPEI, 248 TW 886-2-22903959 / 886-2-22903959	BESMED HEAD STRAP	HEAD STRAP
9	CASTRO EXPORT 16503 N.E. 26TH AVE N. MIAMI BEACH, FL 33160 US 305-945-1197 / 305-945-1197	XCELLENT	FACE MASK
10	CPM DE REYNOSA S.A. DE C.V. BRECHA 99 NTE. PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMP., MX 405-872-3486 / 956-782-9970	STRAP, HEAD, GAS MASK	STRAP, HEAD, GAS MASK
11	EASTMED ENTERPRISES INC. 11 BRANDYWINE DRIVE MARLTON, NJ 08053 US 856-797-0131 / 856-797-0131		VARIOUS TYPES OF HEAD HARNESSES
12	FIONA INC., USA 631 STONE HOUSE LN. MARIETTA, GA 30064 US 770-919-2762 / 770-919-8258	STRAP, HEAD, GAS MASK	DISPOSABLE CAPS & MASKS ETC.
13	FOREMOUNT ENT. CO., LTD. RM. 915, NO.1 LANE 641 SHEN-LIN SOUTH RD. TA YA HSIANG, TAICHUNG, 428 TW 886-4-25605508 / 886-4-25605508	HARNESS	HARNESS
14	GUANGZHOU FORTUNIQUE LTD. BLOCK B 2, ZHOU SHAN GANG SHI BEI INDUSTRIAL AVE., PAN YU DIST., GUANGZHOU, 511410 CH 852-2-376-2855 / 845-469-4289	VARIOUS HEAD STRAPS	HEAD STRAPS
15	HOMEO GREEN LIMITED (JAPAN) HIRATSUKA 2-11-16-1201 SHINAGAWAKU TOKYO, 142-0051 JA 808-591-1660 / 808-591-1660	HAKUJU AND GENERIC MASK	MISCELLANEOUS TYPES AND SIZES OF MASK
16	HOMEO GREEN, INC. 875 WAIMANU ST., #626 HONOLULU, HI 96813 US 808-591-1660 / 808-591-1660	MULTIPLE	VARIOUS
17	INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL P.O. BOX 28, KAMUNTING INDUSTRIAL ESTATE, KAMUNTING PERAK, 34600 MY 919-544-8000 / 919-433-4829	MULTIPLE GAS MASK HEAD STRAPS	VARIOUS TYPES OF GAS MASK HEAD STRAPS
18	INTERSURGICAL, INC. 417 ELECTRONICS PKWY. LIVERPOOL, NY 13088 US 315-451-2900 / 315-451-2900	MULTIPLE	VARIOUS TYPES AND SIZES
19	KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD. 1 SONGJIANG INDUSTRIAL PARK, SONGJIANG SHANGHAI, 201613 CH 886- 2-2680 4986 / 021-577-40705x218	MASK HEADGEAR	HEAD HARNESS
20	NINGBO BESMED MEDICAL EQUIPMENT CORP. NO.51, MO GAN SHAN RD, BEILUN NINGBO, ZHEJIANG, 315800 CH 886-2-22903959 / 886-2-22903959	BESMED HEAD STRAP	HEAD STRAP
21	PEPPER MEDICAL, INC. 907 LENAPE RD. WEST CHESTER, PA 19382 US 800-647-0172 / 800-647-0172	AVALON AIRE HEADSTRAP	CPAP HEADGEAR
22	PT. KARYABUDY EKATAMA JL. RAYA BANDUNG, SOREANG #343 WARUNGLOBAK - KATAPANG BANDUNG, 40971 ID 022-589-1229 / 813-530-7099	MASK HARNESS	HEAD STRAP, VARIOUS TYPES AND SIZES
23	RESQ SOLUTIONS 155 LAUREL WAY COVINGTON, GA 30016 US 770-728-5953 / 770-728-5953	RESUSCITATOR MASK STRAP	FACE MASK STRAP
24	SHARN, INC. 4517 GEORGE RD., SUITE 200 TAMPA, FL 33634 US 813-889-9614 / 813-889-9614	MASK HARNESS	MASK HARNESS
25	TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829	MULTIPLE GAS MASK HEAD STRAPS	VARIOUS TYPES OF GAS MASK HEAD STRAPS
26	TELEFLEX MEDICAL AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA NUEVO LAREDO, TAMAULIPAS, 88275 MX 919-544-8000 / 919-433-4829	MULTIPLE GAS MASK HEAD STRAPS	VARIOUS TYPES OF GAS MASK HEAD STRAPS
27	THE SAUNDERS GROUP 4250 NOREX DR. CHASKA, MN 55318 US 651-415-7469 / 651-415-7469	UTILITY STRAP	VARIOUS SIZES AND USES
28	VADI MEDICAL TECHNOLOGY CO., LTD. 7F-1, NO. 492, SEC. 1 WAN SOU RD., KUEI SHAN HSIANG TAOYUAN HSIEN, 33350 TW 886-2-82092833 / 886-2-82092833	VADI GAS MASK HEAD STRAP	VADI GAS MASK HEAD STRAP
29	VIASYS MEDSYSTEMS 100 CHADDICK DR. WHEELING, IL 60090 US 847-689-8410 / 847-403-3484	PULMAREX HEAD STRAP	HEAD STRAP
30	VITAL SIGNS, INC. 20 CAMPUS RD. TOTOWA, NJ 07512 US 973-790-1330 / 973-790-1330 356	HEADSTRAPS	HEADSTRAPS