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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 K020633
Device Name NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
Applicant
LS RUBBER SDN BHD
11535 PARK WOODS CIRCLE
SUITE B
alpharetta,  GA  30005
Applicant Contact rajila vohra
Correspondent
LS RUBBER SDN BHD
11535 PARK WOODS CIRCLE
SUITE B
alpharetta,  GA  30005
Correspondent Contact rajila vohra
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/27/2002
Decision Date 05/15/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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