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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 K980478
Device Name PLAYTEX TAMPONS #03498
Applicant
Playtex, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Applicant Contact MARK ROSENGARTEN
Correspondent
Playtex, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Correspondent Contact MARK ROSENGARTEN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/06/1998
Decision Date 04/03/1998
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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