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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K884195
Device Name GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)
Applicant
Mumtaz I. Malik
Helm House
100 Diecks Dr.
Elizabethtown,  KY  42701
Applicant Contact MALIK, M.D.
Correspondent
Mumtaz I. Malik
Helm House
100 Diecks Dr.
Elizabethtown,  KY  42701
Correspondent Contact MALIK, M.D.
Regulation Number878.4800
Classification Product Code
GEN  
Date Received10/06/1988
Decision Date 10/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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