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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K954664
Device Name DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING
Applicant
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Applicant Contact ROBERT DIGIOVINE
Correspondent
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Correspondent Contact ROBERT DIGIOVINE
Classification Product Code
MGQ  
Date Received10/10/1995
Decision Date 11/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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