Device Classification Name |
Tampon, Menstrual, Scented, Deodorized
|
510(k) Number |
K111684 |
Device Name |
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD |
Applicant |
PLAYTEX MANUFACTURING INC. |
75 COMMERCE DRIVE |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
PUSHPA RAO |
Correspondent |
PLAYTEX MANUFACTURING INC. |
75 COMMERCE DRIVE |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
PUSHPA RAO |
Regulation Number | 884.5460
|
Classification Product Code |
|
Date Received | 06/15/2011 |
Decision Date | 02/03/2012 |
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
|
|
|