Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K133295 |
Device Name |
QUALIS |
Applicant |
MENICON CO., LTD. NEW BUSINESS DIVISION |
4050 OLSON MEMORIAL HWY, SUITE 450 |
MINNEAPOLIS,
MN
55422
|
|
Applicant Contact |
MARCIA PALMA |
Correspondent |
MENICON CO., LTD. NEW BUSINESS DIVISION |
4050 OLSON MEMORIAL HWY, SUITE 450 |
MINNEAPOLIS,
MN
55422
|
|
Correspondent Contact |
MARCIA PALMA |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 10/25/2013 |
Decision Date | 06/18/2014 |
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
|
|
|