RESTORELLE POLYPROPYLENE Y MESH


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

510(k) Number K112322
Device Name RESTORELLE POLYPROPYLENE Y MESH
Applicant
COLOPLAST A/S
1601 west river road n
minneapolis, 
MN 
55411

Applicant Contact tim crabtree
Correspondent
COLOPLAST A/S
1601 west river road n
minneapolis, 
MN 
55411

Correspodent Contact tim crabtree
Regulation Number 878.3300
Classification Product Code
OTO  
Date Received 08/12/2011
Decision Date 05/17/2012
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