TOUCHLESS TM FOLEY CATHETER KIT

Catheter, Urological

DIAMED DIVISION ILL. TOOL WORKS, INC.

The following data is part of a premarket notification filed by Diamed Division Ill. Tool Works, Inc. with the FDA for Touchless Tm Foley Catheter Kit.

Pre-market Notification Details

Device IDK790728
510k NumberK790728
Device Name:TOUCHLESS TM FOLEY CATHETER KIT
ClassificationCatheter, Urological
Applicant DIAMED DIVISION ILL. TOOL WORKS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-13
Decision Date1979-06-01

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