The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Prosys Samec La.
| Device ID | K963265 |
| 510k Number | K963265 |
| Device Name: | PROSYS SAMEC LA |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Susie Merchant |
| Correspondent | Susie Merchant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1996-10-25 |
| Summary: | summary |