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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 K891500
Device Name EXCELCARE PATIENT EXAMINATION GLOVES
Applicant
Modern Health Care Products
Plot 268, Lorong Perusahaan
Duabelas, Kawasan Perusahaan
Perai,  MY 13600
Applicant Contact SIEW WENG
Correspondent
Modern Health Care Products
Plot 268, Lorong Perusahaan
Duabelas, Kawasan Perusahaan
Perai,  MY 13600
Correspondent Contact SIEW WENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
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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