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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 K924303
Device Name TAMPAX TAMPON, REGULAR ABSORBENCY
Applicant
Tambrands, Inc.
Bridge & Springfield St.s
Palmer,  MA  01069
Applicant Contact BARBARA M DAVIS
Correspondent
Tambrands, Inc.
Bridge & Springfield St.s
Palmer,  MA  01069
Correspondent Contact BARBARA M DAVIS
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/05/1992
Decision Date 07/29/1993
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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