The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Convatec Fecal Management System.
| Device ID | K032734 |
| 510k Number | K032734 |
| Device Name: | CONVATEC FECAL MANAGEMENT SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Nancy Regulski |
| Correspondent | Nancy Regulski CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-04 |
| Decision Date | 2004-04-08 |
| Summary: | summary |