MONARC SLING SYSTEM


Device Classification Name

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

510(k) Number K023516
Device Name MONARC SLING SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka, 
MN 
55343

Original Contact david worrell
Regulation Number 878.3300
Classification Product Code
OTN  
Date Received 10/21/2002
Decision Date 11/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls