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FDA 510(k) Application Details - K092711
Device Classification Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K092711
Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant
ZERUSA LIMITED
219-220 BUSINESS INNOVATION CR
NUIG
GALWAY IE
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Contact
LIAM MULLOY
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Regulation Number
870.4290
More FDA Info for this Regulation Number
Classification Product Code
DTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2009
Decision Date
10/01/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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