FDA 510(k) Application Details - K981870

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K981870
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085-2936 US
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Contact Mark Smutka
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/28/1998
Decision Date 08/20/1998
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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