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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
Model 93-6014, 93-6015
Device Name NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
Applicant
COLOPLAST CORP.
1601 west river n
minneapolis,  MN  55411
Contact margaret batcheleder
Regulation Number878.3300
Classification Product Code
OTO  
Date Received09/25/2012
Decision Date 12/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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