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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 K121241
Device Name MALE LATEX CONDOM
Original Applicant
NULATEX SDN. BHD.
lot 1870, 4th mle
mengkibol
kluang,  MY 86000
Original Contact teo ai siang
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/25/2012
Decision Date 02/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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