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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, 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
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