Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K896994 |
Device Name |
KOTEX SECURITY TAMPONS (SEVERAL TYPE) |
Applicant |
KIMBERLY-CLARK CORP. |
1201 PENNSYLVANIA AVENUE, N.W. |
SUITE 730 |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
BONNIE B WAN |
Correspondent |
KIMBERLY-CLARK CORP. |
1201 PENNSYLVANIA AVENUE, N.W. |
SUITE 730 |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
BONNIE B WAN |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 12/11/1989 |
Decision Date | 12/22/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|