FDA 510(k) Application Details - K071876

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K071876
Device Name Filler, Bone Void, Calcium Compound
Applicant TRIMED, INC.
25864 TOURNAMENT RD. SUITE A
VALENCIA, CA 91355 US
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Contact KELLI ANDERSON
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 07/06/2007
Decision Date 12/17/2007
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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