Device Classification Name |
Media, Reproductive
|
510(k) Number |
K133568 |
Device Name |
G-TL |
Applicant |
VITROLIFE, INC. |
3601 SOUTH INCA ST. |
ENGLEWOOD,
CO
80110
|
|
Applicant Contact |
MARK LARMAN |
Correspondent |
VITROLIFE, INC. |
3601 SOUTH INCA ST. |
ENGLEWOOD,
CO
80110
|
|
Correspondent Contact |
MARK LARMAN |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 11/20/2013 |
Decision Date | 07/16/2014 |
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
|
|
|