Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K874604 |
Device Name |
HISTOBRUSH |
Applicant |
SPECTRUM CO. |
60916 TERMINAL ANNEX |
LOS ANGELES,
CA
90060
|
|
Applicant Contact |
TIMOTHY J WEBBER |
Correspondent |
SPECTRUM CO. |
60916 TERMINAL ANNEX |
LOS ANGELES,
CA
90060
|
|
Correspondent Contact |
TIMOTHY J WEBBER |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/09/1987 |
Decision Date | 01/07/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|