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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 K896114
Device Name TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
Applicant
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Applicant Contact DAVIS, PHD
Correspondent
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Correspondent Contact DAVIS, PHD
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/23/1989
Decision Date 12/13/1989
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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