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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K033696
Device Name PERSONAL INJECTOR
Applicant
Union Medico Aps
Emdrupvej 22
Copenhagen,  DK 2100
Applicant Contact MICHAEL PERTHU
Correspondent
Union Medico Aps
Emdrupvej 22
Copenhagen,  DK 2100
Correspondent Contact MICHAEL PERTHU
Regulation Number880.6920
Classification Product Code
KZH  
Date Received11/25/2003
Decision Date 02/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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