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FDA 510(k) Application Details - K210669
Device Classification Name
Gas Control Unit, Cardiopulmonary Bypass
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510(K) Number
K210669
Device Name
Gas Control Unit, Cardiopulmonary Bypass
Applicant
Spectrum Medical Ltd.
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucestershire GL29QL GB
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Contact
Colleen Powell
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Regulation Number
870.4300
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Classification Product Code
DTX
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More FDA Info for this Product Code
Date Received
03/05/2021
Decision Date
05/04/2021
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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