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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze, external (with drug/biologic/animal source material)
510(k) Number K914937
Device Name STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
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
Classification Product Code
GER  
Date Received11/04/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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