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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 K073662
Device Name PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
Applicant
Playtex Products, Inc.
804 Walker Rd.
Dover,  DE  19904
Applicant Contact KEITH EDGETT
Correspondent
Playtex Products, Inc.
804 Walker Rd.
Dover,  DE  19904
Correspondent Contact KEITH EDGETT
Regulation Number884.5460
Classification Product Code
HIL  
Subsequent Product Code
HEB  
Date Received12/26/2007
Decision Date 01/17/2008
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
Predetermined Change
Control Plan Authorized		 No
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