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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 K974629
Device Name O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
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 Received12/12/1997
Decision Date 02/10/1998
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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