POLYFORM SYNTHETIC MESH

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

PROXY BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Proxy Biomedical Ltd. with the FDA for Polyform Synthetic Mesh.

Pre-market Notification Details

Device IDK051245
510k NumberK051245
Device Name:POLYFORM SYNTHETIC MESH
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Applicant PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
PROXY BIOMEDICAL LTD. P.O. BOX 560 Stillwater,  MN  55082
Product CodeOTO  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-16
Decision Date2005-06-17
Summary:summary

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