Device Classification Name |
electrocautery, gynecologic (and accessories)
|
510(k) Number |
K202915 |
Device Name |
IRIS Thermocoagulator and Digital Colposcope |
Applicant |
Liger Medical, LLC |
3300 North Running Creek Way, Building G, Suite G20 |
Lehi,
UT
84043
|
|
Applicant Contact |
Wm. Dean Wallace |
Correspondent |
Liger Medical, LLC |
3300 North Running Creek Way, Building G, Suite G20 |
Lehi,
UT
84043
|
|
Correspondent Contact |
Wm. Dean Wallace |
Regulation Number | 884.4120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2020 |
Decision Date | 04/23/2021 |
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
|
|
|