Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K902591 |
Device Name |
CYTETTE(TM) CYTOLOGY BRUSH |
Applicant |
BIRCHWOOD LABORATORIES, INC. |
7900 FULLER RD. |
EDEN PRAIRIE,
MN
55344 -2195
|
|
Applicant Contact |
MICHAEL D LENARZ |
Correspondent |
BIRCHWOOD LABORATORIES, INC. |
7900 FULLER RD. |
EDEN PRAIRIE,
MN
55344 -2195
|
|
Correspondent Contact |
MICHAEL D LENARZ |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 06/12/1990 |
Decision Date | 09/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|