RESTORELLE L


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

Correspodent Contact tim crabtree
Regulation Number 878.3300
Classification Product Code
OTO  
Date Received 08/10/2012
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