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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K042314
Device Name SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
Applicant
Biogen
14 Cambridge Center
Cambridge,  MA  02142
Applicant Contact VICTOR J GANGI
Correspondent
Biogen
14 Cambridge Center
Cambridge,  MA  02142
Correspondent Contact VICTOR J GANGI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/26/2004
Decision Date 11/22/2004
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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