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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 K893241
Device Name LATEX EXAM GLOVES
Applicant
Semodal Jaya Sdn. Bhd.
Dmp, Inc.
7003 Brittmoore, Suite 5
Houston,  TX  77041
Applicant Contact JOY CHEW
Correspondent
Semodal Jaya Sdn. Bhd.
Dmp, Inc.
7003 Brittmoore, Suite 5
Houston,  TX  77041
Correspondent Contact JOY CHEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/28/1989
Decision Date 07/14/1989
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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