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First Quality Hygienic, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by FemAugust 5, 2016
K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by FemtNovember 2, 2015
K051446FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONSJuly 14, 2005
K050660FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONSMay 12, 2005
K050067FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFebruary 1, 2005
K032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSSeptember 3, 2003
K031067FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONSJuly 14, 2003
K023479FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGNovember 26, 2002
K963034FEMTEX GENTLE TOUCH TAMPONSNovember 1, 1996
K963032FREE CHOICEOctober 11, 1996
K920238PRIVATE LABELS AND FEMTEXAugust 2, 1993