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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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