FDA 510(k) Application Details - K123268

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K123268
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHOCARE CORPORATION
7000 West William Cannon Drive
Austin, TX 78735 US
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Contact CHERYL FREDERICK
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 10/19/2012
Decision Date 11/07/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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