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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 K083499
Device Name EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
Applicant
COLOPLAST A/S
1499 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact JANELL A COLLEY
Correspondent
COLOPLAST A/S
1499 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact JANELL A COLLEY
Regulation Number884.5980
Classification Product Code
OTP  
Date Received11/25/2008
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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