The following data is part of a premarket notification filed by Convatec Limited with the FDA for Flexi-seal Protect Plus Fecal Management System (with Enfit Connector).
| Device ID | K190114 |
| 510k Number | K190114 |
| Device Name: | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ConvaTec Limited GDC, First Avenue, Deeside Industrial Park Deeside, GB Ch5 2nu |
| Contact | Karen Howes |
| Correspondent | Karen Howes ConvaTec Limited 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 | 2019-01-24 |
| Decision Date | 2019-04-30 |