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FDA 510(k) Application Details - K092541
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K092541
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BIOSTRUCTURES
26552 TAMPICO PLACE
MISSION VIEJO, CA 92691 US
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DAVE BALDING
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
08/19/2009
Decision Date
11/09/2010
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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