Device Classification Name |
Cannula, Intrauterine Insemination
|
510(k) Number |
K931630 |
Device Name |
INSEMI-CATH |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
TAMMY BACON |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
TAMMY BACON |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 04/02/1993 |
Decision Date | 04/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|