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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 K112386
Device Name EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant
COLOPLAST CORP.
1601 WEST RIVER N
MINNEAPOLIS,  MN  55411
Applicant Contact TIM CRABTREE
Correspondent
COLOPLAST CORP.
1601 WEST RIVER N
MINNEAPOLIS,  MN  55411
Correspondent Contact TIM CRABTREE
Regulation Number884.5980
Classification Product Code
OTP  
Date Received08/18/2011
Decision Date 09/08/2011
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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