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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Unscented
510(k) Number K891474
Device Name TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION
Applicant
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Applicant Contact GRESSEL, PH.D.
Correspondent
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Correspondent Contact GRESSEL, PH.D.
Regulation Number884.5435
Classification Product Code
HHD  
Date Received03/16/1989
Decision Date 06/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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