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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 K101113
Device Name GUARDIAN II NC HEMOSTASIS VALVE
Applicant
ZERUSA LIMITED
219-220 BUSINESS INNOVATION
CENTRE NUIG,
GALWAY,  IE
Applicant Contact LIAM MULLOY
Correspondent
ZERUSA LIMITED
219-220 BUSINESS INNOVATION
CENTRE NUIG,
GALWAY,  IE
Correspondent Contact LIAM MULLOY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received04/21/2010
Decision Date 05/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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