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FDA 510(k) Application Details - K102722
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K102722
Device Name
Filler, Bone Void, Calcium Compound
Applicant
SYNTHES USA PRODUCTS LLC
1230 WILSON DRIVE
WEST CHESTER, PA 19380 US
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Contact
JEFFREY L DOW, JD
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
09/21/2010
Decision Date
01/27/2011
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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