MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

Catheter, Straight

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Self-cath Hydrogel Intermittent Catheter.

Pre-market Notification Details

Device IDK050008
510k NumberK050008
Device Name:MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
ClassificationCatheter, Straight
Applicant MENTOR CORP. 201 MENTOR DRIVE Santa Barbara,  CA  93111
ContactDonna A Crawford
CorrespondentDonna A Crawford
MENTOR CORP. 201 MENTOR DRIVE Santa Barbara,  CA  93111
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-03
Decision Date2005-06-03
Summary:summary

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