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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 K070745
Device Name MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC 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 Received03/19/2007
Decision Date 04/13/2007
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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