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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K945145
Device Name RIA LATEX CONDOM, NONOXYNOL-9
Applicant
MBF PERSONAL CARE SDN. BHD.
PLO 22,SENAI INDUSTRIAL ESTATE
PHASE 1
81400 SENAI, JOHOR,  MY 81400
Applicant Contact P K REDDY
Correspondent
MBF PERSONAL CARE SDN. BHD.
PLO 22,SENAI INDUSTRIAL ESTATE
PHASE 1
81400 SENAI, JOHOR,  MY 81400
Correspondent Contact P K REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/20/1994
Decision Date 02/21/1996
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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