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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K901511
Device Name CHISEL, BONE, SURGICAL
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 Number888.4540
Classification Product Code
LXH  
Date Received03/29/1990
Decision Date 09/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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