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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 K990536
Device Name O.B. TAMPON
Applicant
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact RALPH PETRONE
Correspondent
PERSONAL PRODUCTS CO.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact RALPH PETRONE
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/19/1999
Decision Date 08/31/1999
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
Predetermined Change
Control Plan Authorized		 No
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