UROLOGICAL CATHETER AND ACCESSORIES

Stent, Ureteral

APPLIED UROLOGY, INC.

The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Urological Catheter And Accessories.

Pre-market Notification Details

Device IDK925282
510k NumberK925282
Device Name:UROLOGICAL CATHETER AND ACCESSORIES
ClassificationStent, Ureteral
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 CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-20
Decision Date1993-01-13

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