Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K072456 |
Device Name |
DESARA MESH SLING, MODEL CAL-DS01 |
Applicant |
CALDERA MEDICAL, INC. |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Applicant Contact |
CHRISTINE EMANUEL |
Correspondent |
CALDERA MEDICAL, INC. |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Correspondent Contact |
CHRISTINE EMANUEL |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/31/2007 |
Decision Date | 05/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|