The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex Resorb, Model C03-0010 Through C03-090.
| Device ID | K090083 |
| 510k Number | K090083 |
| Device Name: | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY 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 | 2009-01-12 |
| Decision Date | 2009-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D767C0303010 | K090083 | 000 |
| D767C0302010 | K090083 | 000 |
| D767C0301010 | K090083 | 000 |