The following data is part of a premarket notification filed by Bristol-myers Squibb with the FDA for Prosys Bedside Drainage Bag (sterile) Model 650167.
| Device ID | K960949 |
| 510k Number | K960949 |
| Device Name: | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | BRISTOL-MYERS SQUIBB 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Susie Merchant |
| Correspondent | Susie Merchant BRISTOL-MYERS SQUIBB 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-04-19 |
| Summary: | summary |