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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
Original Applicant
COLOPLAST CORP.
1601 west river rd north
minneapolis,  MN  55411
Original 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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