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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 pelvic organ prolapse, transvaginally placed
510(k) Number K082387
Device Name APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55416
Applicant Contact SARAH PETERSON
Correspondent
AMERICAN MEDICAL SYSTEMS
10700 BREN ROAD WEST
MINNETONKA,  MN  55416
Correspondent Contact SARAH PETERSON
Regulation Number884.5980
Classification Product Code
OTP  
Subsequent Product Code
PAI  
Date Received08/19/2008
Decision Date 12/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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