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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 K941863
Device Name O.B. TAMPON
Applicant
PERSONAL PRODUCTS CO.
P.O. BOX 900
MILLTOWN,  NJ  08850 -0900
Applicant Contact R. A PETRONE
Correspondent
PERSONAL PRODUCTS CO.
P.O. BOX 900
MILLTOWN,  NJ  08850 -0900
Correspondent Contact R. A PETRONE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/15/1994
Decision Date 06/27/1994
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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