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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K910723
Device Name BIODEGRADABLE SURGICAL STAPLE
Applicant
Instrument Makar, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Instrument Makar, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3030
Classification Product Code
JDR  
Date Received02/20/1991
Decision Date 03/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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