CONVATEC FECAL MANAGEMENT SYSTEM

Tubes, Gastrointestinal (and Accessories)

CONVATEC, A BRISTOL-MYERS SQUIBB CO.

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.

Pre-market Notification Details

Device IDK032734
510k NumberK032734
Device Name:CONVATEC FECAL MANAGEMENT SYSTEM
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman,  NJ  08558
ContactNancy Regulski
CorrespondentNancy Regulski
CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman,  NJ  08558
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-04
Decision Date2004-04-08
Summary:summary

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