Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K051290 |
Device Name |
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) |
Applicant |
PROCTER & GAMBLE CO. |
6110 CENTER HILL AVE. |
CINCINNATI,
OH
45224
|
|
Applicant Contact |
MARK M ANDERSON |
Correspondent |
PROCTER & GAMBLE CO. |
6110 CENTER HILL AVE. |
CINCINNATI,
OH
45224
|
|
Correspondent Contact |
MARK M ANDERSON |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 05/18/2005 |
Decision Date | 12/27/2005 |
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
|
|
|