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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 K963331
Device Name MEDTEXX
Applicant
Regalfield Sdn. Bhd.
Pt 5054, Kamunting Industrial
Estate, P.O. Box 9, Kamunting
Taiping, Perak,  MY 34600
Applicant Contact LOW BOK TEK
Correspondent
Regalfield Sdn. Bhd.
Pt 5054, Kamunting Industrial
Estate, P.O. Box 9, Kamunting
Taiping, Perak,  MY 34600
Correspondent Contact LOW BOK TEK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/23/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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