KIT PAK URINARY CARE SUPPLIES

Accessories, Catheter, G-u

KIT PAK, INC.

The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Urinary Care Supplies.

Pre-market Notification Details

Device IDK925281
510k NumberK925281
Device Name:KIT PAK URINARY CARE SUPPLIES
ClassificationAccessories, Catheter, G-u
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 CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-20
Decision Date1993-04-19

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