The following data is part of a premarket notification filed by Trilling Resources, Ltd. with the FDA for Water-jel(r) Burn Dressing.
| Device ID | K864841 |
| 510k Number | K864841 |
| Device Name: | WATER-JEL(R) BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | TRILLING RESOURCES, LTD. 250 E. HARTSDALE AVE. Hartsdale, NY 10530 |
| Contact | Cary S Trilling |
| Correspondent | Cary S Trilling TRILLING RESOURCES, LTD. 250 E. HARTSDALE AVE. Hartsdale, NY 10530 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1988-01-22 |