Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K861389 |
Device Name |
PAP SMEAR KIT |
Applicant |
INTL. CYTOBRUSH, INC. |
P.O. BOX 7733 |
HOLLYWOOD,
FL
33081
|
|
Applicant Contact |
TENNY P TSE |
Correspondent |
INTL. CYTOBRUSH, INC. |
P.O. BOX 7733 |
HOLLYWOOD,
FL
33081
|
|
Correspondent Contact |
TENNY P TSE |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/14/1986 |
Decision Date | 05/02/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|