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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 K854258
Device Name PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
Applicant
INTL. PLAYTEX, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Applicant Contact IRWIN BUTENSKY
Correspondent
INTL. PLAYTEX, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5460
Classification Product Code
HIL  
Date Received10/22/1985
Decision Date 11/21/1985
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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