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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, pump speed, cardiopulmonary bypass
510(k) Number K192838
Device Name Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Applicant Contact Colleen Powell
Correspondent
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Correspondent Contact Colleen Powell
Regulation Number870.4380
Classification Product Code
DWA  
Subsequent Product Codes
DTQ   KFM  
Date Received10/03/2019
Decision Date 04/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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