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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, unscented
510(k) Number K904937
Device Name PLAYTEX ULTIMATES UNSCENTED AND SCENTED 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 Number884.5470
Classification Product Code
HEB  
Date Received11/01/1990
Decision Date 03/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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