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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K100432
Device Name POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact MARK FAILLACE
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact MARK FAILLACE
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received02/16/2010
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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