Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K121928 |
Device Name |
DESARA SL |
Applicant |
CALDERA MEDICAL, INC. |
5171 CLARETON DRIVE |
AGOURA HILLS,
CA
91301
|
|
Applicant Contact |
VICKI GAIL |
Correspondent |
CALDERA MEDICAL, INC. |
5171 CLARETON DRIVE |
AGOURA HILLS,
CA
91301
|
|
Correspondent Contact |
VICKI GAIL |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 02/19/2013 |
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
|
|
|