FDA 510(k) Application Details - K960555

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K960555
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant INSTRUMENT MAKAR, INC.
C/O ABOOD,ABOOD & RHEAUME,P.C.
117 EAST ALLEGAN STREET
LANSING, MI 48933 US
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Contact ANDREW P ABOOD
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 02/09/1996
Decision Date 07/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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