The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Conquest Male Continence System.
| Device ID | K942941 |
| 510k Number | K942941 |
| Device Name: | CONQUEST MALE CONTINENCE SYSTEM |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. P.O. BOX CN 5254 Princeton, NJ 08543 -5254 |
| Contact | Marilyn Dreyling |
| Correspondent | Marilyn Dreyling CONVATEC, A BRISTOL-MYERS SQUIBB CO. P.O. BOX CN 5254 Princeton, NJ 08543 -5254 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1995-03-17 |