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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 K023128
Device Name NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
Secure Scientific Sdn Bhd
Lot 122, Kampung Titi Tok Aris
Sungai Seluang
Lunas, Kedah,  MY 09600
Applicant Contact CHONG NGIT-HENG
Correspondent
Secure Scientific Sdn Bhd
Lot 122, Kampung Titi Tok Aris
Sungai Seluang
Lunas, Kedah,  MY 09600
Correspondent Contact CHONG NGIT-HENG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/19/2002
Decision Date 01/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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