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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 K132107
Device Name MALE LATEX CONDOM
Applicant
NULATEX SDN. BHD.
LOT 1870, 4TH MILES JALAN
MENGKIBOL
KLUANG, JOHOR,  MY 86000
Applicant Contact AI SIANG TEO
Correspondent
NULATEX SDN. BHD.
LOT 1870, 4TH MILES JALAN
MENGKIBOL
KLUANG, JOHOR,  MY 86000
Correspondent Contact AI SIANG TEO
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/08/2013
Decision Date 03/07/2014
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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