The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Urihesive Strip.
| Device ID | K915616 |
| 510k Number | K915616 |
| Device Name: | URIHESIVE STRIP |
| Classification | Device, Paste-on For Incontinence, Sterile |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Contact | Marilyn Dreyling |
| Correspondent | Marilyn Dreyling CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 |
| Product Code | EXI |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-01-23 |