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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 K912552
Device Name UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
Applicant
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Applicant Contact PETRONE
Correspondent
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Correspondent Contact PETRONE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received06/11/1991
Decision Date 09/24/1991
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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