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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tampon, Menstrual, Scented, 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 Number884.5460
Classification Product Code
HIL  
Date Received06/02/2005
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
Predetermined Change
Control Plan Authorized		 No
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