FDA 510(k) Application Details - K070293

Device Classification Name Spinal Channeling Instrument, Vertebroplasty

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510(K) Number K070293
Device Name Spinal Channeling Instrument, Vertebroplasty
Applicant BENVENUE MEDICAL, INC.
1235 PEAR AVENUE, #111
MOUNTAIN VIEW, CA 94043 US
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Contact LAURENT SCHALLER
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Regulation Number 888.4540

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Classification Product Code OCJ
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Date Received 01/31/2007
Decision Date 07/10/2007
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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