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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 K893719
Device Name MEDI + FORM EXAM (MFG: GLOVE SEAL SDN BHD)
Applicant
World Impex Corp.
2335 Market St.
Jacksonville,  FL  32206
Applicant Contact GORDON H LAW
Correspondent
World Impex Corp.
2335 Market St.
Jacksonville,  FL  32206
Correspondent Contact GORDON H LAW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/17/1989
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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