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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 K944154
Device Name PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
Applicant
Playtex Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07652
Applicant Contact IRWIN BUTENSKY
Correspondent
Playtex Products, Inc.
215 College Rd.
P.O. Box 728
Paramus,  NJ  07652
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/19/1994
Decision Date 02/09/1995
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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