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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 K020147
Device Name MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
Applicant
Medtronic Perfusion Systems
7611 Northland Dr. N
Brooklyn Park,  MN  55428
Applicant Contact LUCY TAN
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr. N
Brooklyn Park,  MN  55428
Correspondent Contact LUCY TAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/16/2002
Decision Date 04/03/2002
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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