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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K930980
Device Name INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
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 Number888.3040
Classification Product Code
HWC  
Date Received02/25/1993
Decision Date 02/10/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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