Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K953333 |
Device Name |
MENSTRUAL TAMPON |
Applicant |
PARAGON TRADE BRANDS, INC. |
33325 8TH AVENUE SOUTH |
FEDERAL WAY,
WA
98003
|
|
Applicant Contact |
TONY SILWANOWICZ |
Correspondent |
PARAGON TRADE BRANDS, INC. |
33325 8TH AVENUE SOUTH |
FEDERAL WAY,
WA
98003
|
|
Correspondent Contact |
TONY SILWANOWICZ |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 07/17/1995 |
Decision Date | 12/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|