KIT PAK'S FLUSHING KIT

Catheter, Urological

KIT PAK, INC.

The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak's Flushing Kit.

Pre-market Notification Details

Device IDK922051
510k NumberK922051
Device Name:KIT PAK'S FLUSHING KIT
ClassificationCatheter, Urological
Applicant KIT PAK, INC. 825 CHASE AVE. Elk Grove Village,  IL  60007
ContactThomas J Sanders
CorrespondentThomas J Sanders
KIT PAK, INC. 825 CHASE AVE. Elk Grove Village,  IL  60007
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-01
Decision Date1993-06-17

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