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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 K032636
Device Name PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
Applicant
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact KAREN A COSTA
Correspondent
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact KAREN A COSTA
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/27/2003
Decision Date 11/14/2003
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
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