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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 K023333
Device Name MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
Applicant
PLEASURE LATEX PRODUCTS SDN. BHD.
LOT 1365, 17TH MILES, JALAN
SUNGAI SEMBILANG
JERAM, SELANGOR,  MY 45800
Applicant Contact KOI-YONG LIM
Correspondent
PLEASURE LATEX PRODUCTS SDN. BHD.
LOT 1365, 17TH MILES, JALAN
SUNGAI SEMBILANG
JERAM, SELANGOR,  MY 45800
Correspondent Contact KOI-YONG LIM
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received10/07/2002
Decision Date 06/23/2003
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 Yes
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