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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K061078
Device Name BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
Applicant
BRIGHT ELEMENT SDN BHD
OFF JALAN MERU
KLANG SELANGOR DARUL EHSAN,  MY 41050
Applicant Contact SEOW L AUDIE
Correspondent
BRIGHT ELEMENT SDN BHD
OFF JALAN MERU
KLANG SELANGOR DARUL EHSAN,  MY 41050
Correspondent Contact SEOW L AUDIE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/2006
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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