Device Classification Name |
Coagulator, Laparoscopic, Unipolar (And Accessories)
|
510(k) Number |
K181124 |
Device Name |
Acessa ProVu System |
Applicant |
Acessa Health, Inc. |
7004 Bee Cave Road, Bldg 3, Suite 200 |
Austin,
TX
78746
|
|
Applicant Contact |
Brian J. Bergeron |
Correspondent |
Acessa Health, Inc. |
7004 Bee Cave Road, Bldg 3, Suite 200 |
Austin,
TX
78746
|
|
Correspondent Contact |
Kim Rodriguez |
Regulation Number | 884.4160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/30/2018 |
Decision Date | 09/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|