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 |