Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K152843 |
Device Name |
Liger Medical HTU-110 |
Applicant |
LIGER MEDICAL, LLC |
14062 S RUNNING CREEK WAY |
DRAPER,
UT
84020
|
|
Applicant Contact |
STEVE SMITH |
Correspondent |
LIGER MEDICAL, LLC |
14062 S RUNNING CREEK WAY |
DRAPER,
UT
84020
|
|
Correspondent Contact |
STEVE SMITH |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 09/29/2015 |
Decision Date | 06/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|