510(k) K032734

CONVATEC FECAL MANAGEMENT SYSTEM by Convatec, A Bristol-Myers Squibb Co. — Product Code KNT

K032734 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "CONVATEC FECAL MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 2004. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2004
Date Received
September 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type