Device Classification Name |
tampon, menstrual, scented, deodorized
|
510(k) Number |
K022882 |
Device Name |
MODIFICATION TO PLAYTEX TAMPONS #24002 |
Applicant |
PLAYTEX PRODUCTS, INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
PAUL A SIRACUSA |
Correspondent |
PLAYTEX PRODUCTS, INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
PAUL A SIRACUSA |
Regulation Number | 884.5460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/30/2002 |
Decision Date | 09/16/2002 |
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
|
|
|