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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 K943880
Device Name RIA LATEX CONDOM
Applicant
Mbf Personal Care Sdn. Bhd.
Plo 22,Senai Industrial Estate
Phase 1
Senai, Johor,  MY 81400
Applicant Contact T H OOI
Correspondent
Mbf Personal Care Sdn. Bhd.
Plo 22,Senai Industrial Estate
Phase 1
Senai, Johor,  MY 81400
Correspondent Contact T H OOI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/09/1994
Decision Date 02/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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