VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT


Device Classification Name

mesh, surgical, for stress urinary incontinence, male

510(k) Number K111881
Device Name VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
Applicant
COLOPLAST A/S
1601 west river road n
minneapolis, 
MN 
55411

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

Correspodent Contact janell a colley
Regulation Number 878.3300
Classification Product Code
OTM  
Subsequent Product Codes
GAD   KKX  
Date Received 07/01/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No