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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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