LOGO-NU-WAY

Collector, Urine, (and Accessories) For Indwelling Catheter

GARY GIANCARLO

The following data is part of a premarket notification filed by Gary Giancarlo with the FDA for Logo-nu-way.

Pre-market Notification Details

Device IDK800186
510k NumberK800186
Device Name:LOGO-NU-WAY
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant GARY GIANCARLO 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 Received1980-01-29
Decision Date1980-02-26

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