Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K050516 |
FOIA Releasable 510(k) |
K050516
|
Device Name |
T-SLING |
Applicant |
HERNIAMESH S.R.L. |
VIA FRATELLI MELIGA 1/C |
CHIVASSO, TORINO,
IT
10034
|
|
Applicant Contact |
LORENA TRABUCCO |
Correspondent |
HERNIAMESH S.R.L. |
VIA FRATELLI MELIGA 1/C |
CHIVASSO, TORINO,
IT
10034
|
|
Correspondent Contact |
LORENA TRABUCCO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/01/2005 |
Decision Date | 02/03/2006 |
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
|
|
|