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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K921352
Device Name VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
Applicant
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY SCHLAKMAN
Correspondent
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY SCHLAKMAN
Regulation Number880.5200
Classification Product Code
FOS  
Date Received03/19/1992
Decision Date 10/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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