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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, female, mini-sling
510(K) Number K121562
Model 519650
Device Name ALTIS SINGLE INCISION CLING SYSTEM
Applicant
COLOPLAST A/S
1601 west river road north
minneapolis,  MN  55411
Contact janell a colley
Regulation Number878.3300
Classification Product Code
PAH  
Date Received05/29/2012
Decision Date 11/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Clinical Trials NCT01272284
Reviewed by Third Party No
Expedited Review No
Combination Product No
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