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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 K893303
Device Name LATEX EXAMINATION GLOVES
Applicant
MARBLE KING CORP.
7619 EMIL AVE.
BELL GARDENS,  CA  90201
Applicant Contact DAVID LEE
Correspondent
MARBLE KING CORP.
7619 EMIL AVE.
BELL GARDENS,  CA  90201
Correspondent Contact DAVID LEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/18/1989
Decision Date 09/13/1989
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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