Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K141294 |
Device Name |
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS |
Applicant |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Applicant Contact |
CHARNELLE THOMAS |
Correspondent |
KIMBERLY-CLARK CORP. |
1400 HOLCOMB BRIDGE RD. |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
CHARNELLE THOMAS |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 05/19/2014 |
Decision Date | 08/25/2014 |
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
|
|
|