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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K162940
Device Name MultiBand SENSE
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Jan Van de Kerkhof
Correspondent
Philips Medical Systems (Cleveland) Inc.
595 Miner Rd
Cleveland,  OH  44094
Correspondent Contact Susan Quick
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/21/2016
Decision Date 12/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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