Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K151170 |
Device Name |
Tosama 100% Organic Cotton Menstrual Tampon |
Applicant |
TOSAMA D.O.O. |
SARANOVICEVA CESTA 35 VIR |
VIR, DOMZALE,
SI
1230
|
|
Applicant Contact |
MARJETKA KRALJ KUNCIC |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
45 ROCKEFELLER PLAZA |
SUITE 2000 |
NEW YORK,
NY
10111
|
|
Correspondent Contact |
DAVE YUNGVIRT |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 05/01/2015 |
Decision Date | 07/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|