Device Classification Name |
Cap, Cervical
|
510(k) Number |
K870551 |
Device Name |
INTRAUTERINE INSEMINATION CATHETER |
Applicant |
COOK OB/GYN |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
DEXTER J ELKINS |
Correspondent |
COOK OB/GYN |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
DEXTER J ELKINS |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 02/10/1987 |
Decision Date | 03/02/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|