The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex Mesh.
| Device ID | K021511 |
| 510k Number | K021511 |
| Device Name: | CYTOFLEX MESH |
| Classification | Plate, Bone |
| Applicant | UNICARE BIOMEDICAL, INC. 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang UNICARE BIOMEDICAL, INC. 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-09 |
| Decision Date | 2002-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D767C0245010 | K021511 | 000 |
| D767C0244010 | K021511 | 000 |
| D767C0241010 | K021511 | 000 |
| D767C0243010 | K021511 | 000 |
| D767C0242010 | K021511 | 000 |