URETERAL STENT

Stent, Ureteral

APPLIED UROLOGY, INC.

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

Pre-market Notification Details

Device IDK920695
510k NumberK920695
Device Name:URETERAL STENT
ClassificationStent, Ureteral
Applicant APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills,  CA  92653
ContactO Stegwell
CorrespondentO 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 Received1992-02-14
Decision Date1992-09-23

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