Device Classification Name |
mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K031295 |
Device Name |
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
FRANCES E HARRISON |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
FRANCES E HARRISON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/23/2003 |
Decision Date | 05/15/2003 |
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
|
|
|