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FDA 510(k) Application Details - K052381
Device Classification Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K052381
Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant
ZERUSA LIMITED
219-220 BUSINESS INNOVATION
CENTRE NUIG, NEWCASTLE RD
GALWAY IE
Other 510(k) Applications for this Company
Contact
OONAGH SWEENEY
Other 510(k) Applications for this Contact
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
08/30/2005
Decision Date
11/21/2005
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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