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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K092711
Device Name GUARDIAN II HEMOSTASIS VALVE
Applicant
Zerusa Limited
219-220 Business Innovation Cr
Nuig
Galway,  IE
Applicant Contact LIAM MULLOY
Correspondent
Zerusa Limited
219-220 Business Innovation Cr
Nuig
Galway,  IE
Correspondent Contact LIAM MULLOY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/03/2009
Decision Date 10/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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