Device Classification Name |
Media, Reproductive
|
510(k) Number |
K121572 |
Device Name |
CONTINUOUS SINGLE CULTURE COMPLETE |
Applicant |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
JAYME YAMAGUCHI-OWENS |
Correspondent |
IRVINE SCIENTIFIC SALES CO., INC. |
2511 DAIMLER ST |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
JAYME YAMAGUCHI-OWENS |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 05/29/2012 |
Decision Date | 07/19/2012 |
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
|
|
|