Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K191666 |
Device Name |
Unscented W long plastic and cardboard applicator tampons |
Applicant |
ONTEX BVBA |
5 Genthof |
Buggenhout Oost - Vlaanderen,
BE
9255
|
|
Applicant Contact |
Henri Lesage |
Correspondent |
Emergo Europe Consulting |
Prinsessegracht 20 |
The Hague,
NL
2514AP
|
|
Correspondent Contact |
Rachel Paul |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 06/21/2019 |
Decision Date | 12/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|