RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K103568
Device Name RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
Applicant
COLOPLAST A/S
1601 west river road north
minneapolis, 
MN 
55411

Applicant Contact janell a colley
Correspondent
COLOPLAST A/S
1601 west river road north
minneapolis, 
MN 
55411

Correspodent Contact janell a colley
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 12/06/2010
Decision Date 12/22/2010
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

Recalls CDRH Recalls