OSFERION D

Bone Grafting Material, Synthetic

OLYMPUS TERUMO BIOMATERIALS CORPORATION

The following data is part of a premarket notification filed by Olympus Terumo Biomaterials Corporation with the FDA for Osferion D.

Pre-market Notification Details

Device IDK081561
510k NumberK081561
Device Name:OSFERION D
ClassificationBone Grafting Material, Synthetic
Applicant OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactStacy A Kluesner
CorrespondentStacy A Kluesner
OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-03
Decision Date2008-07-28
Summary:summary

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