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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K943249
Device Name BIOABSORBABLE INTERFERENCE SCREW
Applicant
Instrument Makar, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact PARTRICIA B SHRADER
Correspondent
Instrument Makar, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact PARTRICIA B SHRADER
Regulation Number888.3030
Classification Product Code
MAI  
Date Received07/06/1994
Decision Date 07/31/1995
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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