EVACUATION KIT #7-510-14

Laparoscope, General & Plastic Surgery

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Evacuation Kit #7-510-14.

Pre-market Notification Details

Device IDK914861
510k NumberK914861
Device Name:EVACUATION KIT #7-510-14
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-29
Decision Date1992-01-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.