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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 K010931
Device Name AMS SACRAL COLPOPEXY SLING, MODEL 72403501
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact ELSA A LINKE
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact ELSA A LINKE
Regulation Number878.3300
Classification Product Code
OTO  
Date Received03/28/2001
Decision Date 04/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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