CONVEEN LEG BAG STRAP

Bag, Urine Collection, Leg, For External Use, Sterile

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Conveen Leg Bag Strap.

Pre-market Notification Details

Device IDK953783
510k NumberK953783
Device Name:CONVEEN LEG BAG STRAP
ClassificationBag, Urine Collection, Leg, For External Use, Sterile
Applicant COLOPLAST CORP. 1955 WEST OAK CIR. Marietta,  GA  30062 -2249
ContactMary Lee Lewis
CorrespondentMary Lee Lewis
COLOPLAST CORP. 1955 WEST OAK CIR. Marietta,  GA  30062 -2249
Product CodeFAQ  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-14
Decision Date1995-09-13

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