FDA 510(k) Application Details - K092898

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K092898
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO, FL 33773-4908 US
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Contact LORNA K LINVILLE
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 09/21/2009
Decision Date 10/19/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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