FDA 510(k) Application Details - K051820

Device Classification Name Injector, Vertebroplasty (Does Not Contain Cement)

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510(K) Number K051820
Device Name Injector, Vertebroplasty (Does Not Contain Cement)
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 888.4200

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Classification Product Code OAR
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Date Received 07/05/2005
Decision Date 09/06/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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