FDA 510(k) Application Details - K101448

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K101448
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE, CA 94085-3523 US
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Contact LAURA N KASPEROWICZ
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 05/24/2010
Decision Date 06/21/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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