The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Torrentx Wound Wash.
| Device ID | K203446 |
| 510k Number | K203446 |
| Device Name: | TorrentX Wound Wash |
| Classification | Dressing, Wound, Drug |
| Applicant | Next Science, LLC 10550 Deerwood Park Blvd Ste 300 Jacksonville, FL 32256 |
| Contact | Courtney Narain |
| Correspondent | Courtney Narain Next Science, LLC 10550 Deerwood Park Blvd Ste 300 Jacksonville, FL 32256 |
| 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 | 2020-11-23 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370858000164 | K203446 | 000 |