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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 K122968
Device Name NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
Applicant
Coloplast Corp.
1601 W. River N
Minneapolis,  MN  55411
Applicant Contact MARGARET BATCHELDER
Correspondent
Coloplast Corp.
1601 W. River N
Minneapolis,  MN  55411
Correspondent Contact MARGARET BATCHELDER
Regulation Number878.3300
Classification Product Code
OTO  
Date Received09/25/2012
Decision Date 12/18/2012
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
Predetermined Change
Control Plan Authorized		 No
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