Device Classification Name |
media, reproductive
|
510(k) Number |
K002383 |
Device Name |
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT |
Applicant |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Applicant Contact |
BRENDA DAVIS |
Correspondent |
COOK OB/GYN |
1100 WEST MORGAN ST. |
P.O. BOX 271 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
BRENDA DAVIS |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 08/04/2000 |
Decision Date | 09/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|