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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 K844935
Device Name ORIGINAL REGULAR TAMPAX TAMPONS
Applicant
TAMBRANDS, INC.
2020 K ST. NW
WASHINGTON,  DC  20006
Applicant Contact JOHN FELLMAN
Correspondent
TAMBRANDS, INC.
2020 K ST. NW
WASHINGTON,  DC  20006
Correspondent Contact JOHN FELLMAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/19/1984
Decision Date 02/07/1985
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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