Device Classification Name |
cannula, intrauterine insemination
|
510(k) Number |
K953719 |
Device Name |
HUMAN TUBAL FLUID |
Applicant |
LIFE TECHNOLOGIES, INC. |
3175 STALEY RD. |
P. O. BOX 68 |
GRAND ISLAND,
NY
14072
|
|
Applicant Contact |
KEITH D GITTERMANN |
Correspondent |
LIFE TECHNOLOGIES, INC. |
3175 STALEY RD. |
P. O. BOX 68 |
GRAND ISLAND,
NY
14072
|
|
Correspondent Contact |
KEITH D GITTERMANN |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 08/09/1995 |
Decision Date | 11/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|