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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K173834
Device Name Quantum Pump Console
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Applicant Contact Mark Drain
Correspondent
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Correspondent Contact Mark Drain
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received12/18/2017
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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