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FDA 510(k) Application Details - K071876
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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