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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
Applicant Contact R. A PETRONE
Correspondent
Personal Products Co.
P.O. Box 900
Milltown,  NJ  08850
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
Predetermined Change
Control Plan Authorized		 No
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