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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 K062730
Device Name NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
Applicant
BIOGREEN MEDICAL SDN. BHD.
OFF 3/4 MILE JALAN BERCHAM
KAWASAN PERINDUSTRIAN BERCHAM
ipoh, perak,  MY 31400
Applicant Contact sri mahendra sathiacama
Correspondent
BIOGREEN MEDICAL SDN. BHD.
OFF 3/4 MILE JALAN BERCHAM
KAWASAN PERINDUSTRIAN BERCHAM
ipoh, perak,  MY 31400
Correspondent Contact sri mahendra sathiacama
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/13/2006
Decision Date 10/05/2006
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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