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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 K945802
Device Name DERMAGRAN WOUND CLEANSER WITH ZINC
Applicant
DERMA SCIENCES, INC.
121 WEST GRACE ST.
OLD FORGE,  PA  18518
Applicant Contact MARY G CLARK
Correspondent
DERMA SCIENCES, INC.
121 WEST GRACE ST.
OLD FORGE,  PA  18518
Correspondent Contact MARY G CLARK
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/28/1994
Decision Date 02/27/1995
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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