FDA 510(k) Application Details - K133727

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K133727
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORPORATION
7000 West William Cannon Drive
Austin, TX 78735 US
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Contact MITCHELL DHORITY
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 12/06/2013
Decision Date 01/16/2014
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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