Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K130609 |
Device Name |
VEEDA 100% COTTON MENSTRUAL TAMPON |
Applicant |
NATURALENA BRANDS, INC. |
1875 S. GRANT ST. |
SUITE 570 |
SAN MATEO,
CA
94402
|
|
Applicant Contact |
JOSH ELLIS |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 03/07/2013 |
Decision Date | 03/21/2013 |
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
|
|
|