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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 K100807
Model 720181, 720191
Device Name MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Contact donna semlak
Regulation Number878.3300
Classification Product Code
PAH  
Date Received03/22/2010
Decision Date 06/07/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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