ELECTROSURGICAL ELECRTRODES

Hysteroscope (and Accessories)

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Electrosurgical Elecrtrodes.

Pre-market Notification Details

Device IDK962271
510k NumberK962271
Device Name:ELECTROSURGICAL ELECRTRODES
ClassificationHysteroscope (and Accessories)
Applicant NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin,  IL  60123
ContactCasey Kurek
CorrespondentCasey Kurek
NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin,  IL  60123
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-13
Decision Date1997-08-08
Summary:summary

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