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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 K970954
Device Name O.B. APPLICATOR TAMPONS
Applicant
PERSONAL PRODUCTS CO.
GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact RALPH A PETRONE
Correspondent
PERSONAL PRODUCTS CO.
GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact RALPH A PETRONE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received03/17/1997
Decision Date 06/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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