SD-200IEHL(TM)

Lithotriptor, Electro-hydraulic

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Sd-200iehl(tm).

Pre-market Notification Details

Device IDK914517
510k NumberK914517
Device Name:SD-200IEHL(TM)
ClassificationLithotriptor, Electro-hydraulic
Applicant NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
ContactScott K Gilchrist
CorrespondentScott K Gilchrist
NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
Product CodeFFK  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-09
Decision Date1992-06-30

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