Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K890848 |
Device Name |
CERVEX-BRUSH |
Applicant |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Applicant Contact |
ANTHONY HEMMING |
Correspondent |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Correspondent Contact |
ANTHONY HEMMING |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/21/1989 |
Decision Date | 05/11/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|