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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
510(k) Number K121928
Model CAL-DS01 SL
Device Name DESARA SL
Original Applicant
5171 clareton drive
agoura hills,  CA  91301
Original Contact vicki gail
Regulation Number878.3300
Classification Product Code
Date Received07/02/2012
Decision Date 02/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No