Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K991253 |
Device Name |
FALCON IVF ROUND DISH |
Applicant |
BECTON DICKINSON LABWARE |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07465 -1886
|
|
Applicant Contact |
DAVID BALL |
Correspondent |
BECTON DICKINSON LABWARE |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07465 -1886
|
|
Correspondent Contact |
DAVID BALL |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 04/13/1999 |
Decision Date | 05/05/1999 |
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
|
|
|