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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 K893725
Device Name PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
Applicant
Playtex Family Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Applicant Contact BUTENSKY, PHD.
Correspondent
Playtex Family Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Correspondent Contact BUTENSKY, PHD.
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/17/1989
Decision Date 08/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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