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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, Internal
510(k) Number K893902
Device Name 4 X 4 STERILE GAUZE SPONGE TRAY
Applicant
Mumtaz I. Malik
Helm House
100 Diecks Dr.
Elizabethtown,  KY  42701
Applicant Contact M. I MALIK
Correspondent
Mumtaz I. Malik
Helm House
100 Diecks Dr.
Elizabethtown,  KY  42701
Correspondent Contact M. I MALIK
Classification Product Code
EFQ  
Date Received05/30/1989
Decision Date 07/14/1989
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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