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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K896455
Device Name VITACHOICE WOUND DRESSING
Applicant
VITAPHORE CORP.
1505 O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact JAN TOMSIC
Correspondent
VITAPHORE CORP.
1505 O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact JAN TOMSIC
Regulation Number880.5240
Classification Product Code
KGX  
Date Received11/09/1989
Decision Date 02/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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