The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Next Science Wound Gel.
Device ID | K150792 |
510k Number | K150792 |
Device Name: | Next Science Wound Gel |
Classification | Dressing, Wound, Drug |
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 | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2015-03-25 |
Decision Date | 2015-12-17 |
Summary: | summary |