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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 K851356
Device Name PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
Applicant
INTL. PLAYTEX, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Applicant Contact IRWIN BUTENSKY
Correspondent
INTL. PLAYTEX, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07652
Correspondent Contact IRWIN BUTENSKY
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/04/1985
Decision Date 04/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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