Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K802193 |
Device Name |
KOTEX SECURITY TUBE TAMPONS |
Applicant |
KIMBERLY-CLARK CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KIMBERLY-CLARK CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 09/10/1980 |
Decision Date | 11/12/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|