Device Classification Name |
Coagulator, Laparoscopic, Unipolar (And Accessories)
|
510(k) Number |
K121858 |
Device Name |
THE ABLATION SYSTEM |
Applicant |
HALT MEDICAL INC. |
131 Sand Creek Road, Suite B |
Brentwood,
CA
94513
|
|
Applicant Contact |
CLARISA TATE |
Correspondent |
HALT MEDICAL INC. |
131 Sand Creek Road, Suite B |
Brentwood,
CA
94513
|
|
Correspondent Contact |
CLARISA TATE |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 06/26/2012 |
Decision Date | 11/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00874029
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|