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
|
|
Correspondent Contact |
JEFF MORGAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/02/2011 |
Decision Date | 06/30/2011 |
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
|
|
|