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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, deodorized
510(k) Number K861738
Device Name PLAYTEX TAMPONS
Applicant
INTL. PLAYTEX, INC.
700 FAIRFIELD AVE.
P.O. BOX 10064
STAMFORD,  CT  06904
Applicant Contact BRUCE J WENDEL
Correspondent
INTL. PLAYTEX, INC.
700 FAIRFIELD AVE.
P.O. BOX 10064
STAMFORD,  CT  06904
Correspondent Contact BRUCE J WENDEL
Regulation Number884.5460
Classification Product Code
HIL  
Date Received05/06/1986
Decision Date 07/22/1986
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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