Device Classification Name |
media, reproductive
|
510(k) Number |
K133912 |
Device Name |
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO |
Applicant |
ORIGIO A/S |
Knardrupvej 2 |
Maaloev,
DK
DK-2760
|
|
Applicant Contact |
TOVE KJAER |
Correspondent |
ORIGIO A/S |
Knardrupvej 2 |
Maaloev,
DK
DK-2760
|
|
Correspondent Contact |
TOVE KJAER |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 12/23/2013 |
Decision Date | 05/14/2014 |
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 |
Yes
|
|
|