The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Convatec Fecal Management System.
Device ID | K032734 |
510k Number | K032734 |
Device Name: | CONVATEC FECAL MANAGEMENT SYSTEM |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Contact | Nancy Regulski |
Correspondent | Nancy Regulski CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. 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 | 2003-09-04 |
Decision Date | 2004-04-08 |
Summary: | summary |