MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Obtape Trans-obturator Surgical Kit.

Pre-market Notification Details

Device IDK042851
510k NumberK042851
Device Name:MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant MENTOR CORP. 201 MENTOR DRIVE Santa Barbara,  CA  93111
ContactDonna Crawford
CorrespondentDonna Crawford
MENTOR CORP. 201 MENTOR DRIVE Santa Barbara,  CA  93111
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-15
Decision Date2004-11-09
Summary:summary

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