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FDA 510(k) Application Details - K081561
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K081561
Device Name
Bone Grafting Material, Synthetic
Applicant
OLYMPUS TERUMO BIOMATERIALS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact
STACY A KLUESNER
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
06/03/2008
Decision Date
07/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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