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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K914579
Device Name SILVER FOAM WOUND DRESSING
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
Classification Product Code
FRO  
Date Received10/16/1991
Decision Date 02/21/1992
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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