Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

Caldera Medical, Inc.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack.

Pre-market Notification Details

Device IDK191416
510k NumberK191416
Device Name:Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Applicant Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills,  CA  91301
ContactVicki Gail
CorrespondentVicki Gail
Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills,  CA  91301
Product CodePAH  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-28
Decision Date2020-02-07

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