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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 K020201
Device Name PLAYTEX DEODORANT TAMPONS, MODEL 34902
Applicant
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact MARK ROSENGARTEN
Correspondent
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact MARK ROSENGARTEN
Regulation Number884.5460
Classification Product Code
HIL  
Date Received01/22/2002
Decision Date 03/12/2002
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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