The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex Tefguard Ti-enforced Membrane.
| Device ID | K151344 |
| 510k Number | K151344 |
| Device Name: | Cytoflex Tefguard Ti-Enforced Membrane |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | Unicare Biomedical, Inc. 23011 Moulton Parkway, J-11 Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang Unicare Biomedical, Inc. 23011 Moulton Parkway, J-11 Laguna Hills, CA 92653 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-19 |
| Decision Date | 2015-11-19 |
| Summary: | summary |