Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K871552 |
Device Name |
ORTHO* SPECIMEN COLLECTION CYTOBRUSH |
Applicant |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
1125 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
MCCLAIN, PHD |
Correspondent |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
1125 MARK AVE. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
MCCLAIN, PHD |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/22/1987 |
Decision Date | 06/26/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|