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FDA 510(k) Application Details - K012751
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K012751
Device Name
Filler, Bone Void, Calcium Compound
Applicant
ORQUEST, INC.
365 RAVENDALE DR.
MOUNTAIN VIEW, CA 94043-5712 US
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Contact
KRISTINE F LAHMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
08/16/2001
Decision Date
11/14/2001
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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