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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, long-term greater than 30 days
510(k) Number K954302
Device Name VYGON PREMI-CATH - LONG TERM CATHETER
Applicant
VYGON CORP.
304 VERONA AVE.
ELIZABETH,  NJ  07208
Applicant Contact HARRY A SCHLAKMAN
Correspondent
VYGON CORP.
304 VERONA AVE.
ELIZABETH,  NJ  07208
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/13/1995
Decision Date 06/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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