FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES


Device Classification Name

tampon, menstrual, unscented

510(k) Number K023479
Device Name FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
Original Applicant
FIRST QUALITY HYGIENIC, INC.
73 franklin turnpike
allendale, 
NJ 
07401

Original Contact robert j staab
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 10/17/2002
Decision Date 11/26/2002
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

Recalls CDRH Recalls