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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 pelvic organ prolapse, transvaginally placed
510(k) Number K083722
Device Name ASCEND
Original Applicant
28632 roadside dr., suite 260
agoura hills,  CA  91301
Original Contact mara korsunsky
Regulation Number878.3300
Classification Product Code
Date Received12/15/2008
Decision Date 03/31/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No