FDA 510(k) Application Details - K110183

Device Classification Name Cement, Bone, Vertebroplasty

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510(K) Number K110183
Device Name Cement, Bone, Vertebroplasty
Applicant ARTHROCARE CORP.
680 VAQUEROS AVE.
SUNNYVALE, CA 94085-3523 US
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Contact VALERIE DEFIESTA-NG
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Regulation Number 888.3027

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Classification Product Code NDN
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Date Received 01/21/2011
Decision Date 02/16/2011
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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