Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K123641 |
Device Name |
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH |
Applicant |
HERTART |
KORSKILDELUND 6 |
GREVE,
DK
2670
|
|
Applicant Contact |
HENRIK DORGE |
Correspondent |
HERTART |
KORSKILDELUND 6 |
GREVE,
DK
2670
|
|
Correspondent Contact |
HENRIK DORGE |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 11/26/2012 |
Decision Date | 07/03/2013 |
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
|
|
|