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FDA 510(k) Application Details - K080065
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K080065
Device Name
Filler, Bone Void, Calcium Compound
Applicant
OLYMPUS TERUMO BIOMATERIALS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS-TYLER
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
01/10/2008
Decision Date
05/02/2008
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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