Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K141663 |
Device Name |
EEVA DISH (WITH 12 MICROWELLS) |
Applicant |
AUXOGYN, INC. |
1490 O'BRIEN DRIVE, SUITE A |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
JULIA S ANASTAS |
Correspondent |
AUXOGYN, INC. |
1490 O'BRIEN DRIVE, SUITE A |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
JULIA S ANASTAS |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 06/23/2014 |
Decision Date | 07/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|