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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 K013773
Device Name SAFE
Applicant
SSN MEDICAL PRODUCTS SDN. BHD.
NO. 1, JALAN 203, OFF JALAN
TANDANG
PETALING JAYA, SELANGOR,  MY 46050
Applicant Contact ANG TECK LEONG
Correspondent
SSN MEDICAL PRODUCTS SDN. BHD.
NO. 1, JALAN 203, OFF JALAN
TANDANG
PETALING JAYA, SELANGOR,  MY 46050
Correspondent Contact ANG TECK LEONG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/13/2001
Decision Date 01/24/2002
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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