Device Classification Name |
Media, Reproductive
|
510(k) Number |
K100367 |
Device Name |
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 |
Applicant |
ORIGIO A/S |
9915 CAM, CHIRIMOLLA |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
RONALD G LEONARDI |
Correspondent |
ORIGIO A/S |
9915 CAM, CHIRIMOLLA |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
RONALD G LEONARDI |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 02/12/2010 |
Decision Date | 08/27/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|