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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 apical vaginal and uterine prolapse, transabdominally placed
510(k) Number K120327
Device Name VERTESSA
Original Applicant
5171 clareton drive
agoura hills,  CA  91301
Original Contact vicki gail
Regulation Number878.3300
Classification Product Code
Date Received02/02/2012
Decision Date 05/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No