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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 K032425
Device Name INVISIJECT RESUSABLE AUTO-INJECTOR
Applicant
Biogen
14 Cambridge Center
Cambridge,  MA  02142
Applicant Contact Michael Poirier
Correspondent
Biogen
14 Cambridge Center
Cambridge,  MA  02142
Correspondent Contact Michael Poirier
Regulation Number880.6920
Classification Product Code
KZH  
Date Received08/06/2003
Decision Date 11/05/2003
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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