RECIRCULATION KIT #7-510-18

Insufflator, Laparoscopic

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Recirculation Kit #7-510-18.

Pre-market Notification Details

Device IDK914402
510k NumberK914402
Device Name:RECIRCULATION KIT #7-510-18
ClassificationInsufflator, Laparoscopic
Applicant NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
ContactPeter A Manzie
CorrespondentPeter A Manzie
NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-02
Decision Date1991-11-27

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