Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K001119 |
Device Name |
ROVERS ENDOCERVEX-BRUSH |
Applicant |
ROVERS MEDICAL DEVICES B.V. |
960 CHAPEA RD. |
PASADENA,
CA
91107
|
|
Applicant Contact |
TODD M GATES |
Correspondent |
ROVERS MEDICAL DEVICES B.V. |
960 CHAPEA RD. |
PASADENA,
CA
91107
|
|
Correspondent Contact |
TODD M GATES |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/07/2000 |
Decision Date | 05/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|