The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Prosys Leg Bag.
| Device ID | K951945 |
| 510k Number | K951945 |
| Device Name: | PROSYS LEG BAG |
| Classification | Bag, Urine Collection, Leg, For External Use, 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 | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-26 |
| Decision Date | 1995-05-25 |