GMD UNIVERSAL URINARY INCONTINENCE SLING


Device Classification Name

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

510(k) Number K111219
Device Name GMD UNIVERSAL URINARY INCONTINENCE SLING
Applicant
GENERIC MEDICAL DEVICE, INC.
po box 818
ocean shores, 
WA 
98569

Applicant Contact jeff morgan
Correspondent
GENERIC MEDICAL DEVICE, INC.
po box 818
ocean shores, 
WA 
98569

Correspodent Contact jeff morgan
Regulation Number 878.3300
Classification Product Code
OTN  
Date Received 05/02/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No