ENDOSCOPIC ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

APPLIED UROLOGY, INC.

The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Endoscopic Electrode.

Pre-market Notification Details

Device IDK912656
510k NumberK912656
Device Name:ENDOSCOPIC ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-17
Decision Date1991-09-16

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