EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

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

COLOPLAST CORP.

The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Exair Anterior And Posterior Prolapse Repair System.

Pre-market Notification Details

Device IDK112386
510k NumberK112386
Device Name:EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Applicant COLOPLAST CORP. 1601 WEST RIVER N Minneapolis,  MN  55411
ContactTim Crabtree
CorrespondentTim Crabtree
COLOPLAST CORP. 1601 WEST RIVER N Minneapolis,  MN  55411
Product CodeOTP  
CFR Regulation Number884.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-18
Decision Date2011-09-08
Summary:summary

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