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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K963602
Device Name BIODERM PVP FOAM WOUND DRESSING
Applicant
BIODERM, INC.
P.O. BOX 4882
WHEATON,  IL  60189
Applicant Contact GEORGE WORTHLEY
Correspondent
BIODERM, INC.
P.O. BOX 4882
WHEATON,  IL  60189
Correspondent Contact GEORGE WORTHLEY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/09/1996
Decision Date 10/30/1996
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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