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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 K811992
Device Name ASSURE NATURAL FIT TAMPON
Applicant
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Applicant Contact A.J. Huetteman
Correspondent
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Correspondent Contact A.J. Huetteman
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/13/1981
Decision Date 07/20/1981
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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