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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 K912002
Device Name PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
Applicant
PLAYTEX FAMILY PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07653
Applicant Contact IRWIN BUTENSKY
Correspondent
PLAYTEX FAMILY PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07653
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5460
Classification Product Code
HIL  
Date Received05/06/1991
Decision Date 08/12/1991
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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