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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 K060981
Device Name PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
Applicant
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact KEITH EDGETT
Correspondent
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact KEITH EDGETT
Regulation Number884.5460
Classification Product Code
HIL  
Date Received04/10/2006
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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