GENERAL USE KIT #7-510-20

Insufflator, Laparoscopic

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for General Use Kit #7-510-20.

Pre-market Notification Details

Device IDK914403
510k NumberK914403
Device Name:GENERAL USE KIT #7-510-20
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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10817183020346 K914403 000
10817183020339 K914403 000
10817183020322 K914403 000
10817183020308 K914403 000
23596010463818 K914403 000
03596010463821 K914403 000
03596010126795 K914403 000
00817183020707 K914403 000

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