FDA 510(k) Application Details - K123240

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K123240
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORPORATION
7000 W William Cannon Dr
Austin, TX 78735 US
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Contact CHERYL FREDERICK
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 10/16/2012
Decision Date 02/14/2013
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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