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 |