The following data is part of a premarket notification filed by Water-jel Technologies, Inc. with the FDA for Water Jel Burn Kit.
| Device ID | K952561 |
| 510k Number | K952561 |
| Device Name: | WATER JEL BURN KIT |
| Classification | First Aid Kit With Drug |
| Applicant | WATER-JEL TECHNOLOGIES, INC. 243 VETERANS BLVD. Carlstadt, NJ 07072 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky WATER-JEL TECHNOLOGIES, INC. 243 VETERANS BLVD. Carlstadt, NJ 07072 |
| Product Code | LRR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-02 |
| Decision Date | 1995-07-14 |