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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, Scented-Deodorized
510(k) Number K936189
Device Name PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
Applicant
Playtex Family Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Applicant Contact IRWIN BUTENSKY
Correspondent
Playtex Family Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07653
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5460
Classification Product Code
HIL  
Subsequent Product Code
HEB  
Date Received12/27/1993
Decision Date 03/07/1994
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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