Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K172504 |
Device Name |
Tosama Biobased Applicator Tube Menstrual Tampon |
Applicant |
TOSAMA, d.o.o. |
Saranoviceva cesta 35 |
Vir,
SI
1230
|
|
Applicant Contact |
Marjetka Kralj Kuncic |
Correspondent |
TOSAMA, d.o.o. |
Saranoviceva cesta 35 |
Vir,
SI
1230
|
|
Correspondent Contact |
Janez Obreza |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 08/18/2017 |
Decision Date | 02/09/2018 |
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
|
|
|