FDA 510(k) Application Details - K073054

Device Classification Name Screw, Fixation, Bone

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510(K) Number K073054
Device Name Screw, Fixation, Bone
Applicant CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
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Contact DAVID J COLLETTE
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 10/30/2007
Decision Date 11/27/2007
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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