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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 K913344
Device Name DERMAGRAN WET DRESSING (ZINC-SALINE)
Applicant
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Applicant Contact MARY G CLARK
Correspondent
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Correspondent Contact MARY G CLARK
Classification Product Code
MGQ  
Date Received07/26/1991
Decision Date 07/14/1992
Decision Substantially Equivalent (SESE)
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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