Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K851934 |
Device Name |
CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA |
Applicant |
TRIDAK DIVISION OF INDICON, INC. |
ONE BLUE HILL PLAZA |
SUITE 815 |
PEARL RIVER,
NY
10965
|
|
Applicant Contact |
CORINNE M AMBROSINO |
Correspondent |
TRIDAK DIVISION OF INDICON, INC. |
ONE BLUE HILL PLAZA |
SUITE 815 |
PEARL RIVER,
NY
10965
|
|
Correspondent Contact |
CORINNE M AMBROSINO |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/06/1985 |
Decision Date | 07/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|