The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Water Jel Sterile Gel-soaked Burn Dressing.
| Device ID | K892360 |
| 510k Number | K892360 |
| Device Name: | WATER JEL STERILE GEL-SOAKED BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Contact | David Oppenheimer |
| Correspondent | David Oppenheimer PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| 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 | 1989-04-06 |
| Decision Date | 1989-06-05 |