DESARA BLUE OV, DESARA BLUE SS

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

CALDERA MEDICAL

The following data is part of a premarket notification filed by Caldera Medical with the FDA for Desara Blue Ov, Desara Blue Ss.

Pre-market Notification Details

Device IDK140843
510k NumberK140843
Device Name:DESARA BLUE OV, DESARA BLUE SS
ClassificationMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Applicant CALDERA MEDICAL 5171 Clareton Dr Agoura Hills,  CA  91301
ContactVicki Gail
CorrespondentVicki Gail
CALDERA MEDICAL 5171 Clareton Dr Agoura Hills,  CA  91301
Product CodeOTN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-02
Decision Date2014-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00890594000728 K140843 000
00890594000698 K140843 000

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