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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 K963603
Device Name DERMAGRAN HYDROPHILIC OINTMENT
Applicant
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Applicant Contact MARK G CLARK
Correspondent
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Correspondent Contact MARK G CLARK
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/09/1996
Decision Date 11/27/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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