FLO ASSISTANT, MODEL 4-250-00

System, Irrigation, Urological

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Flo Assistant, Model 4-250-00.

Pre-market Notification Details

Device IDK001325
510k NumberK001325
Device Name:FLO ASSISTANT, MODEL 4-250-00
ClassificationSystem, Irrigation, Urological
Applicant NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin,  IL  60123
ContactCasey Kurek
CorrespondentCasey Kurek
NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin,  IL  60123
Product CodeLJH  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-26
Decision Date2000-08-18

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