Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K070047 |
Device Name |
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH |
Applicant |
NUNC A/S |
KAMSTRUPUEJ 90, KAMSTRUP |
ROSKILDE,
DK
DK-4000
|
|
Applicant Contact |
JANA S HELLMANN |
Correspondent |
NUNC A/S |
KAMSTRUPUEJ 90, KAMSTRUP |
ROSKILDE,
DK
DK-4000
|
|
Correspondent Contact |
JANA S HELLMANN |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 01/04/2007 |
Decision Date | 05/18/2007 |
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
|
|
|