UROLOGICAL STONE BASKET

Dislodger, Stone, Basket, Ureteral, Metal

NORTHGATE RESEARCH, INC.

The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for Urological Stone Basket.

Pre-market Notification Details

Device IDK891254
510k NumberK891254
Device Name:UROLOGICAL STONE BASKET
ClassificationDislodger, Stone, Basket, Ureteral, Metal
Applicant NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights,  IL  60004
ContactCharles P Gill
CorrespondentCharles P Gill
NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights,  IL  60004
Product CodeFFL  
CFR Regulation Number876.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-08
Decision Date1989-03-22

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