SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE

Stent, Ureteral

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Silicone Double Coil Ureteral Stent With Suture.

Pre-market Notification Details

Device IDK862539
510k NumberK862539
Device Name:SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
ClassificationStent, Ureteral
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactKaren Edwards
CorrespondentKaren Edwards
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-02
Decision Date1986-09-09

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