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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, disposable
510(k) Number K853597
Device Name INSTRUMENT MAKAR DISPOSALBE LOOP
Applicant
INSTRUMENT MAKAR, INC.
815 CONNECTICUT AVE.
WASHINGTON,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
INSTRUMENT MAKAR, INC.
815 CONNECTICUT AVE.
WASHINGTON,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Regulation Number878.4800
Classification Product Code
KDC  
Date Received08/27/1985
Decision Date 09/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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