Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K930955 |
Device Name |
CERVEX-BRUSH |
Applicant |
ROVERS B.V. |
108 UNION ST. |
ROCKAWAY,
NJ
07866
|
|
Applicant Contact |
JOHN RICHARDSON |
Correspondent |
ROVERS B.V. |
108 UNION ST. |
ROCKAWAY,
NJ
07866
|
|
Correspondent Contact |
JOHN RICHARDSON |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/23/1993 |
Decision Date | 05/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|