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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: HEB Applicant: FIRST QUALITY HYGIENIC, INC. Decision Date To: 05/21/2024
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opal by femtex pull & snap and private label unscented compact applicator tampon, regularopal by femtex pull & snap and private label unscented compact applicator tampon, super, opal by femtex pull & snap and private label unscented compact applicator tampon, super pl FIRST QUALITY HYGIENIC, INC. K161877 08/05/2016
opal by femtex and private label unscented compact applicator tampon, light absorbency; opal by femtex and private label unscented compact applicator tampon, regular & super; opal by femtex and private label unscented compact applicator tampon, super plus; opal by femtex and private label unscented FIRST QUALITY HYGIENIC, INC. K151470 11/02/2015
femtex and private label plastic applicator tampons FIRST QUALITY HYGIENIC, INC. K050660 05/12/2005
femtex junior/slender regular open-end tampons FIRST QUALITY HYGIENIC, INC. K031067 07/14/2003
femtex tampons and other private label plastic applicator tampons; consumer packages and bulk packages FIRST QUALITY HYGIENIC, INC. K023479 11/26/2002
femtex gentle touch tampons FIRST QUALITY HYGIENIC, INC. K963034 11/01/1996
free choice FIRST QUALITY HYGIENIC, INC. K963032 10/11/1996
private labels and femtex FIRST QUALITY HYGIENIC, INC. K920238 08/02/1993
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