Device Classification Name |
cannula, intrauterine insemination
|
510(k) Number |
K914150 |
Device Name |
JANSEN-ANDERSON INSEMINATION SET |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
MICHELLE YOUNG |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
MICHELLE YOUNG |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 09/16/1991 |
Decision Date | 09/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|