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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 K982380
Device Name SURE
Applicant
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Applicant Contact CHANG AH KAU
Correspondent
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Correspondent Contact CHANG AH KAU
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/08/1998
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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