Device Classification Name |
Tampon, Menstrual, Scented, Deodorized
|
510(k) Number |
K051446 |
Device Name |
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS |
Applicant |
FIRST QUALITY HYGIENIC INC. |
73 FRANKLIN TPK |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
ROBERT J STAAB |
Correspondent |
FIRST QUALITY HYGIENIC INC. |
73 FRANKLIN TPK |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
ROBERT J STAAB |
Regulation Number | 884.5460
|
Classification Product Code |
|
Date Received | 06/02/2005 |
Decision Date | 07/14/2005 |
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
|
|
|