Device Classification Name |
media, reproductive
|
510(k) Number |
K112083 |
Device Name |
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES |
Applicant |
<GENX> INTL., INC. |
393 SOUNDVIEW RD. |
GUILFORD,
CT
06437
|
|
Applicant Contact |
MICHAEL D CECCHI |
Correspondent |
INTL., INC. |
393 SOUNDVIEW RD. |
GUILFORD,
CT
06437
|
|
Correspondent Contact |
MICHAEL D CECCHI |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 07/21/2011 |
Decision Date | 05/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|