Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K103028 |
Device Name |
EEVATM PETRI DISH |
Applicant |
AUXOGYN, INC. |
1490 O'BRIEN DRIVE |
SUITE A |
MENLO PARK,
CA
94545
|
|
Applicant Contact |
ROBERT NEWMAN |
Correspondent |
AUXOGYN, INC. |
1490 O'BRIEN DRIVE |
SUITE A |
MENLO PARK,
CA
94545
|
|
Correspondent Contact |
ROBERT NEWMAN |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 10/13/2010 |
Decision Date | 08/11/2011 |
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
|
|
|