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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 K780648
Device Name MODIFIED UNTREATED 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 Received04/17/1978
Decision Date 05/31/1978
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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