The following data is part of a premarket notification filed by Convatec with the FDA for Flexi-seal Protect Fecal Management System.
| Device ID | K162906 |
| 510k Number | K162906 |
| Device Name: | Flexi-Seal PROTECT Fecal Management System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ConvaTec GDC, First Avenue, Deeside Industrial Park Deeside, GB Ch5 2nu |
| Contact | Karen Howes |
| Correspondent | Karen Howes ConvaTec GDC, First Avenue, Deeside Industrial Park Deeside, GB Ch5 2nu |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-03-07 |
| Summary: | summary |