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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 K180167
Device Name Playtex Stella Tampons
Applicant
Playtex Manufacturing, Inc.
804 Walker Rd.
Dover,  DE  19904
Applicant Contact Ludjane Fiorillo
Correspondent
Edgewell Personal Care
75 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact Danielle Vitale
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/22/2018
Decision Date 05/30/2018
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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