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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 K820174
Device Name TAMPAX TAMPONS
Applicant
TAMPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TAMPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/21/1982
Decision Date 03/18/1982
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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