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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 K832818
Device Name UNSCENTED MENSTRUAL TAMPON
Applicant
BNT CO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BNT CO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/19/1983
Decision Date 01/17/1984
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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