The following data is part of a premarket notification filed by Trilling Medical Technologies, Inc. with the FDA for Water Jel Sterile Gel-soaked Burn Dressing.
| Device ID | K900516 |
| 510k Number | K900516 |
| Device Name: | WATER JEL STERILE GEL-SOAKED BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | TRILLING MEDICAL TECHNOLOGIES, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky TRILLING MEDICAL TECHNOLOGIES, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-03-19 |