The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Prosys Bedside Drainage Bag.
| Device ID | K953767 |
| 510k Number | K953767 |
| Device Name: | PROSYS BEDSIDE DRAINAGE BAG |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Susie Amberger |
| Correspondent | Susie Amberger CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-11 |
| Decision Date | 1995-12-20 |