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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
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