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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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