ALTIS SINGLE INCISION CLING SYSTEM


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

510(k) Number K121562
Device Name ALTIS SINGLE INCISION CLING SYSTEM
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
PAH  
Date Received 05/29/2012
Decision Date 11/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Clinical Trials NCT01272284
Reviewed by Third Party No

Combination Product

No