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FDA 510(k) Application Details - K212657
Device Classification Name
Controller, Temperature, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K212657
Device Name
Controller, Temperature, Cardiopulmonary Bypass
Applicant
Spectrum Medical Ltd.
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL29QL GB
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Contact
Colleen Powell
Other 510(k) Applications for this Contact
Regulation Number
870.4250
More FDA Info for this Regulation Number
Classification Product Code
DWC
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More FDA Info for this Product Code
Date Received
08/23/2021
Decision Date
05/06/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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