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FDA 510(k) Application Details - K191246
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K191246
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
Chalice Medical Ltd
Manton Wood Enterprise Park,
Worksop S80 2RS GB
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Contact
Carol Middleton
Other 510(k) Applications for this Contact
Regulation Number
870.4350
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Classification Product Code
DTZ
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More FDA Info for this Product Code
Date Received
05/09/2019
Decision Date
02/28/2020
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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