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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 K843551
Device Name PLAYTEX BABY POWDER DEODORANT TAMPONS
Applicant
Playtex, Inc.
P.O. Box 728
Paramus,  NJ  07652
Applicant Contact IRWIN BUTENSKY
Correspondent
Playtex, Inc.
P.O. Box 728
Paramus,  NJ  07652
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5460
Classification Product Code
HIL  
Date Received09/10/1984
Decision Date 12/03/1984
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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