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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 K002571
Device Name MULITPLE MALE LATX CONDOM
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  
Date Received08/18/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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