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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 K132061
Device Name RESTORELLE M, RESTORELLE XL
Applicant
COLOPLAST CORP.
1601 WEST RIVER
MINNEAPOLIS,  MN  55411
Applicant Contact TIM CRABTREE
Correspondent
COLOPLAST CORP.
1601 WEST RIVER
MINNEAPOLIS,  MN  55411
Correspondent Contact TIM CRABTREE
Regulation Number878.3300
Classification Product Code
OTO  
Date Received07/03/2013
Decision Date 08/02/2013
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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