Device Classification Name |
spatula, cervical, cytological
|
510(k) Number |
K153128 |
Device Name |
Kolplast Cervical Sample Collection Kit |
Applicant |
KOLPLAST CI SA |
ESTRADA MUNICIPAL IVA 136. NO 418. BARRIO DA MINA |
ITUPEVA- SP,
BR
13295-000
|
|
Applicant Contact |
DANIELA FERACIN |
Correspondent |
Smith Assoicates |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/29/2015 |
Decision Date | 01/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|