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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 K864498
Device Name O.B.(TM) TAMPON
Applicant
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Applicant Contact A. J HUETTEMAN
Correspondent
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Correspondent Contact A. J HUETTEMAN
Regulation Number884.5460
Classification Product Code
HIL  
Date Received11/14/1986
Decision Date 01/27/1987
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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