EVACUATOR, GASTRO-UROLOGY

Evacuator, Gastro-urology

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Evacuator, Gastro-urology.

Pre-market Notification Details

Device IDK921088
510k NumberK921088
Device Name:EVACUATOR, GASTRO-UROLOGY
ClassificationEvacuator, Gastro-urology
Applicant NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
ContactDaniel Kamm
CorrespondentDaniel Kamm
NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
Product CodeKQT  
CFR Regulation Number876.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-06
Decision Date1992-10-28

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