Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K895675 |
Device Name |
PAP SMEAR TRAY |
Applicant |
INTL. CYTOBRUSH, INC. |
P.O. BOX 7733 |
HOLLYWOOD,
FL
33081
|
|
Applicant Contact |
TSE, PH.D. |
Correspondent |
INTL. CYTOBRUSH, INC. |
P.O. BOX 7733 |
HOLLYWOOD,
FL
33081
|
|
Correspondent Contact |
TSE, PH.D. |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/20/1989 |
Decision Date | 12/11/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|