The following data is part of a premarket notification filed by Water-jel Technologies, Llc. with the FDA for Burn Jel Plus.
| Device ID | K003396 |
| 510k Number | K003396 |
| Device Name: | BURN JEL PLUS |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | WATER-JEL TECHNOLOGIES, LLC. 243 VETERANS BLVD. Carlstadt, NJ 07072 |
| Contact | Michael Pisani |
| Correspondent | Michael Pisani WATER-JEL TECHNOLOGIES, LLC. 243 VETERANS BLVD. Carlstadt, NJ 07072 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-01-11 |