The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Next Science Wound Gel (rx).
| Device ID | K163188 |
| 510k Number | K163188 |
| Device Name: | Next Science Wound Gel (Rx) |
| Classification | Dressing, Wound, Drug |
| Applicant | Next Science, LLC 8130 Baymeadows Way W, Suite 200 Jacksonville, FL 32256 |
| Contact | Matthew Myntti |
| Correspondent | Matthew Myntti Next Science, LLC 8130 Baymeadows Way W, Suite 200 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 | 2016-11-14 |
| Decision Date | 2017-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370858000096 | K163188 | 000 |
| 00370858000089 | K163188 | 000 |
| 00370858000072 | K163188 | 000 |
| 00370858000041 | K163188 | 000 |
| 00864076000285 | K163188 | 000 |
| 00864076000216 | K163188 | 000 |