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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, deodorized
510(k) Number K872258
Device Name TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS
Applicant
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Applicant Contact STAAB, PHD
Correspondent
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Correspondent Contact STAAB, PHD
Regulation Number884.5460
Classification Product Code
HIL  
Date Received06/10/1987
Decision Date 07/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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