SUPRIS RETROPUBIC SLING SYSTEM


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

510(k) Number K111233
Device Name SUPRIS RETROPUBIC SLING SYSTEM
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
OTN  
Date Received 05/02/2011
Decision Date 06/24/2011
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