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510(k) Data Aggregation
K Number
K023128Device Name
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Manufacturer
Date Cleared
2003-01-22
(125 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SECURE SCIENTIFIC SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
Not Found
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