The following data is part of a premarket notification filed by Convatec Ltd. with the FDA for Flexi-seal Signal Fecal Management System.
Device ID | K150350 |
510k Number | K150350 |
Device Name: | Flexi-Seal Signal Fecal Management System |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ConvaTec Ltd. Unit 20, First Ave, Deeside Industrial Park Deeside, GB Ch5 2nu |
Contact | Clare Williamson |
Correspondent | Clare Williamson ConvaTec Ltd. Unit 20, First Ave, 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 | 2015-02-11 |
Decision Date | 2015-07-21 |
Summary: | summary |