The following data is part of a premarket notification filed by Bionova Medical Inc. with the FDA for Foundation Dermal Regeneration Scaffold (drs) Solo.
| Device ID | K210949 |
| 510k Number | K210949 |
| Device Name: | Foundation Dermal Regeneration Scaffold (DRS) Solo |
| Classification | Dressing, Wound, Drug |
| Applicant | Bionova Medical Inc. 3012 Centre Oak Way, Ste 102 Germantown, TN 38138 |
| Contact | Alex Greene |
| Correspondent | Alex Greene Bionova Medical Inc. 3012 Centre Oak Way, Ste 102 Germantown, TN 38138 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-30 |
| Decision Date | 2022-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850047730077 | K210949 | 000 |
| 00850047730060 | K210949 | 000 |
| 00850047730053 | K210949 | 000 |
| 00850047730046 | K210949 | 000 |
| 00850047730039 | K210949 | 000 |
| 00850047730022 | K210949 | 000 |
| 00850047730015 | K210949 | 000 |
| 00850047730008 | K210949 | 000 |