FDA 510(k) Application Details - K001588

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K001588
Device Name Probe, Radiofrequency Lesion
Applicant ARTHROCARE CORP.
595 NORTH PASTORIA AVE.
SUNNYVALE, CA 94085-2936 US
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Contact BRUCE PROTHRO
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 05/23/2000
Decision Date 08/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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