FDA 510(k) Application Details - K014304

Device Classification Name Screw, Fixation, Bone

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510(K) Number K014304
Device Name Screw, Fixation, Bone
Applicant TRIAGE MEDICAL INC
13700 ALTON PKWY.
SUITE 167
IRVINE, CA 92618 US
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Contact BRAD CULBERT
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 12/31/2001
Decision Date 03/27/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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