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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K914071
Device Name MULTIPLE BURN DRESSING
Applicant
Kerma Medical Products, Inc.
1801-P Sara Dr.
Chesapeake,  VA  23320
Applicant Contact BESSIE N TODD
Correspondent
Kerma Medical Products, Inc.
1801-P Sara Dr.
Chesapeake,  VA  23320
Correspondent Contact BESSIE N TODD
Regulation Number878.4014
Classification Product Code
NAB  
Date Received09/11/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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