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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 K874509
Device Name PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
Applicant
Playtex, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Applicant Contact BUTENSKY, PHD
Correspondent
Playtex, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Correspondent Contact BUTENSKY, PHD
Regulation Number884.5460
Classification Product Code
HIL  
Date Received11/02/1987
Decision Date 01/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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