EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

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

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Exair Anterior And Posterior Prolapse Repair Systems.

Pre-market Notification Details

Device IDK083499
510k NumberK083499
Device Name:EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Applicant COLOPLAST A/S 1499 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
ContactJanell A Colley
CorrespondentJanell A Colley
COLOPLAST A/S 1499 WEST RIVER ROAD NORTH Minneapolis,  MN  55411
Product CodeOTP  
CFR Regulation Number884.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-25
Decision Date2009-05-08
Summary:summary

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