Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
|
510(k) Number |
K191416 |
Device Name |
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |
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 |
|
Subsequent Product Code |
|
Date Received | 05/28/2019 |
Decision Date | 02/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|