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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
Original Applicant
COLOPLAST A/S
1499 west river road north
minneapolis,  MN  55411
Original Contact janell a colley
Regulation Number878.3300
Classification Product Code
OTP  
Date Received11/25/2008
Decision Date 05/08/2009
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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