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FDA 510(k) Application Details - K111018
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K111018
Device Name
Filler, Bone Void, Calcium Compound
Applicant
ATPAC MEDICAL LLC
848 N RAINBOW BLVD
LAS VEGAS, NV 89107 US
Other 510(k) Applications for this Company
Contact
GARY MALINOWSKI
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
04/12/2011
Decision Date
02/14/2012
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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