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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, Drug
510(k) Number K924754
Device Name DERMAGRAN WOUND DRESSING
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
FRO  
Date Received09/23/1992
Decision Date 05/27/1993
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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