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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 K963396
Device Name BIOSPHERE SUTURE ANCHOR
Applicant
Instrument Makar, Inc.
C/O Abood,Abood & Rheaume,P.C.
117 E. Allegan St.
Lansing,  MI  48933
Applicant Contact ANDREW P ABOOD
Correspondent
Instrument Makar, Inc.
C/O Abood,Abood & Rheaume,P.C.
117 E. Allegan St.
Lansing,  MI  48933
Correspondent Contact ANDREW P ABOOD
Regulation Number888.3030
Classification Product Code
MAI  
Date Received08/28/1996
Decision Date 05/06/1997
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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