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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 K895920
Device Name VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS
Applicant
VITAPHORE CORP.
1505 O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact SOPHIA PESOTCHINSKY
Correspondent
VITAPHORE CORP.
1505 O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact SOPHIA PESOTCHINSKY
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/11/1989
Decision Date 06/06/1991
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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