The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for United Skin Barriers.
| Device ID | K844938 |
| 510k Number | K844938 |
| Device Name: | UNITED SKIN BARRIERS |
| Classification | Collector, Ostomy |
| Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Contact | Sheldon Steinberg |
| Correspondent | Sheldon Steinberg PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-20 |
| Decision Date | 1985-01-18 |