The following data is part of a premarket notification filed by Omeza, Llc with the FDA for Omeza Collagen Matrix.
| Device ID | K211972 |
| 510k Number | K211972 |
| Device Name: | Omeza Collagen Matrix |
| Classification | Dressing, Wound, Drug |
| Applicant | Omeza, LLC 25 South Osprey Avenue Sarasota, FL 34236 |
| Contact | Thomas Gardner |
| Correspondent | Randy Prebula Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-06-24 |
| Decision Date | 2021-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859839007205 | K211972 | 000 |
| 00859839007212 | K211972 | 000 |