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FDA 510(k) Application Details - K051047
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K051047
Device Name
Filler, Bone Void, Calcium Compound
Applicant
OSSACUR AG
975 VERONICA SPRINGS ROAD
SANTA BARBARA, CA 93105 US
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Contact
KRISTI KISTNER
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
04/25/2005
Decision Date
03/08/2006
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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