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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 K122440
Device Name RESTORELLE L
Applicant
COLOPLAST CORP.
1601 WEST RIVER RD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact TIM CRABTREE
Correspondent
COLOPLAST CORP.
1601 WEST RIVER RD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact TIM CRABTREE
Regulation Number878.3300
Classification Product Code
OTO  
Date Received08/10/2012
Decision Date 11/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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