FDA 510(k) Application Details - K993339

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

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510(K) Number K993339
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
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Contact LAURA SENEFF
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Regulation Number 888.3030

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Classification Product Code MAI
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Date Received 10/05/1999
Decision Date 12/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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