MAC LEE UI URINE COLLECTION BAG

Collector, Urine, (and Accessories) For Indwelling Catheter

MAC LEE MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Mac Lee Ui Urine Collection Bag.

Pre-market Notification Details

Device IDK830192
510k NumberK830192
Device Name:MAC LEE UI URINE COLLECTION BAG
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant MAC LEE MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-20
Decision Date1983-02-01

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