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FDA 510(k) Application Details - K052098
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K052098
Device Name
Filler, Bone Void, Calcium Compound
Applicant
ISOTIS ORTHOBIOLOGICS, INC
2 GOODYEAR, SUITE B
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
PAUL DONER
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
08/03/2005
Decision Date
09/07/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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