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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 K994311
Device Name MALE LATEX CONDOM WITH VANILLA FLAVOR
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 Number884.5300
Classification Product Code
HIS  
Date Received12/22/1999
Decision Date 03/21/2000
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
Predetermined Change
Control Plan Authorized		 No
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