Device Classification Name |
Tampon, Menstrual, Scented, Deodorized
|
510(k) Number |
K914438 |
Device Name |
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS |
Applicant |
PLAYTEX FAMILY PRODUCTS, INC. |
215 COLLEGE RD. |
P.O. BOX 728 |
PARAMUS,
NJ
07653
|
|
Applicant Contact |
IRWIN BUTENSKY |
Correspondent |
PLAYTEX FAMILY PRODUCTS, INC. |
215 COLLEGE RD. |
P.O. BOX 728 |
PARAMUS,
NJ
07653
|
|
Correspondent Contact |
IRWIN BUTENSKY |
Regulation Number | 884.5460
|
Classification Product Code |
|
Date Received | 10/04/1991 |
Decision Date | 01/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|