The following data is part of a premarket notification filed by Convatec Inc with the FDA for Flexi-seal Signal Fecal Management System.
| Device ID | K112342 |
| 510k Number | K112342 |
| Device Name: | FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman, NJ 08558 |
| Contact | Katrina Fiedler |
| Correspondent | Katrina Fiedler CONVATEC INC 200 HEADQUARTERS PARK DRIVE 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 | 2011-08-15 |
| Decision Date | 2012-04-26 |
| Summary: | summary |