RIGID URETEROSCOPE

Ureteroscope And Accessories, Flexible/rigid

APPLIED UROLOGY, INC.

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

Pre-market Notification Details

Device IDK901214
510k NumberK901214
Device Name:RIGID URETEROSCOPE
ClassificationUreteroscope And Accessories, Flexible/rigid
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 CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-14
Decision Date1990-06-01

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