MENTOR NOVASILK MESH

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Novasilk Mesh.

Pre-market Notification Details

Device IDK053414
510k NumberK053414
Device Name:MENTOR NOVASILK MESH
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
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 CodeOTP  
Subsequent Product CodeOTO
Subsequent Product CodePAI
Subsequent Product CodePAJ
CFR Regulation Number884.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-07
Decision Date2005-12-27
Summary:summary

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