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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom With Nonoxynol-9
510(k) Number K001377
Device Name SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Applicant Contact LIM KOI-YONG
Correspondent
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Correspondent Contact LIM KOI-YONG
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received05/01/2000
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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