The following data is part of a premarket notification filed by Olympus Terumo Biomaterials Corporation with the FDA for Osferion D.
Device ID | K081561 |
510k Number | K081561 |
Device Name: | OSFERION D |
Classification | Bone Grafting Material, Synthetic |
Applicant | OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Contact | Stacy A Kluesner |
Correspondent | Stacy A Kluesner OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-03 |
Decision Date | 2008-07-28 |
Summary: | summary |