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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K882407
Device Name BOW & ARROW DRILL GUIDE
Applicant
INSTRUMENT MAKAR, INC.
2950 EAST MT. HOPE RD.
OKEMOS,  MI  48864
Applicant Contact DEAN Z LOOK
Correspondent
INSTRUMENT MAKAR, INC.
2950 EAST MT. HOPE RD.
OKEMOS,  MI  48864
Correspondent Contact DEAN Z LOOK
Regulation Number878.4820
Classification Product Code
LXI  
Date Received06/10/1988
Decision Date 09/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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