FDA 510(k) Application Details - K143235

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K143235
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORPORATION
7000 WEST WILLIAM CANNON DRIVE
AUSTIN, TX 78735 US
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Contact Ashley J Dawson
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 11/10/2014
Decision Date 10/23/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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