The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Next Science Irrigation Solution.
| Device ID | K161165 |
| 510k Number | K161165 |
| Device Name: | Next Science Irrigation Solution |
| Classification | Lavage, Jet |
| Applicant | NEXT SCIENCE, LLC 8130 BAYMEADOWS WAY WEST, SUITE 200 Jacksonville, FL 33256 |
| Contact | Matthew Myntti |
| Correspondent | Matthew Myntti NEXT SCIENCE, LLC 8130 BAYMEADOWS WAY WEST, SUITE 200 Jacksonville, FL 33256 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864076000209 | K161165 | 000 |
| 00864076000292 | K161165 | 000 |