Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K092607 |
Device Name |
AJUST ADJUSTABLE SINGLE INCISION SLING |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
JOHN C KNORPP |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
JOHN C KNORPP |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/25/2009 |
Decision Date | 11/20/2009 |
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
|
|
|