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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 K123819
Device Name MULTIPLE NAME
Applicant
Top Calibre Sdn Bhd
1-1,2 Jalan Setia Prima U13/S
Setia Alam, Seksyen U13
Shah Alam,  MY 40170
Applicant Contact ROSNITA MAODIN
Correspondent
Top Calibre Sdn Bhd
1-1,2 Jalan Setia Prima U13/S
Setia Alam, Seksyen U13
Shah Alam,  MY 40170
Correspondent Contact ROSNITA MAODIN
Regulation Number880.6250
Classification Product Code
LYY  
Subsequent Product Code
LZC  
Date Received12/12/2012
Decision Date 03/05/2013
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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