Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K092054 |
Device Name |
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON |
Applicant |
TOSAMA D.D. |
SARANOVICEVA CESTA 035 |
VIR, DOMZALE,
SI
1230
|
|
Applicant Contact |
ANTONIJA VIDENSEK |
Correspondent |
TOSAMA D.D. |
SARANOVICEVA CESTA 035 |
VIR, DOMZALE,
SI
1230
|
|
Correspondent Contact |
ANTONIJA VIDENSEK |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 07/07/2009 |
Decision Date | 07/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|