The following data is part of a premarket notification filed by Olympus Terumo Biomaterials Corporation with the FDA for Foundation.
Device ID | K111087 |
510k Number | K111087 |
Device Name: | FOUNDATION |
Classification | Bone Grafting Material, Synthetic |
Applicant | OLYMPUS TERUMO BIOMATERIALS CORPORATION 5600 WISONSIN AVENUE, #509 Chevy Chase, MD 20815 |
Contact | Patsy J Trisler |
Correspondent | Patsy J Trisler OLYMPUS TERUMO BIOMATERIALS CORPORATION 5600 WISONSIN AVENUE, #509 Chevy Chase, MD 20815 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-19 |
Decision Date | 2011-11-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14560245656828 | K111087 | 000 |
14560245656811 | K111087 | 000 |