The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Bactisure Wound Lavage.
| Device ID | K192349 |
| 510k Number | K192349 |
| Device Name: | Bactisure Wound Lavage |
| Classification | Lavage, Jet |
| Applicant | Next Science, LLC 10550 Deerwood Park Blvd., Ste. 300 Jacksonville, FL 32256 |
| Contact | Jeanne Lee |
| Correspondent | Jeanne Lee Next Science, LLC 10550 Deerwood Park Blvd., Ste. 300 Jacksonville, FL 32256 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-08-29 |
| Decision Date | 2020-01-23 |