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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 K893071
Device Name PATIENT EXAM GLOVES (MFG. KOON SENG)
Applicant
Innovative Medical Suppliers
221 W. E St., Suite 201
Encinitas,  CA  92024
Applicant Contact JOSEPH G OSBORNE
Correspondent
Innovative Medical Suppliers
221 W. E St., Suite 201
Encinitas,  CA  92024
Correspondent Contact JOSEPH G OSBORNE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/13/1989
Decision Date 05/21/1990
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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