Device Classification Name |
Tampon, Menstrual, Scented, Deodorized
|
510(k) Number |
K132819 |
Device Name |
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS |
Applicant |
PLAYTEX MANUFACTURING INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
PUSHPA RAO |
Correspondent |
PLAYTEX MANUFACTURING INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
PUSHPA RAO |
Regulation Number | 884.5460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2013 |
Decision Date | 10/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|