Device Classification Name |
media, reproductive
|
510(k) Number |
K032877 |
Device Name |
G-OOCYTE |
Applicant |
VITROLIFE SWEDEN AB |
1800 MASSACHUSETTS AVENUE NW |
WASHINGTON,
DC
20036 -1800
|
|
Applicant Contact |
GARY L YINGLING |
Correspondent |
VITROLIFE SWEDEN AB |
1800 MASSACHUSETTS AVENUE NW |
WASHINGTON,
DC
20036 -1800
|
|
Correspondent Contact |
GARY L YINGLING |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 09/15/2003 |
Decision Date | 05/07/2004 |
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
|
|
|