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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, Scented, Scented-Deodorized
510(k) Number K953638
Device Name O.B. APPLICATOR TAMPONS
Applicant
Personal Products Co.
Van Liew Ave.
P.O. Box 900
Milltown,  NJ  08850
Applicant Contact RALPH A PETRONE
Correspondent
Personal Products Co.
Van Liew Ave.
P.O. Box 900
Milltown,  NJ  08850
Correspondent Contact RALPH A PETRONE
Regulation Number884.5460
Classification Product Code
HIL  
Date Received08/04/1995
Decision Date 10/20/1995
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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