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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 K111684
Device Name PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
Applicant
Playtex Manufacturing, Inc.
75 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact PUSHPA RAO
Correspondent
Playtex Manufacturing, Inc.
75 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact PUSHPA RAO
Regulation Number884.5460
Classification Product Code
HIL  
Date Received06/15/2011
Decision Date 02/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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