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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 K052381
Device Name GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
Applicant
ZERUSA LIMITED
219-220 BUSINESS INNOVATION
CENTRE NUIG, NEWCASTLE RD
GALWAY,  IE
Applicant Contact OONAGH SWEENEY
Correspondent
ZERUSA LIMITED
219-220 BUSINESS INNOVATION
CENTRE NUIG, NEWCASTLE RD
GALWAY,  IE
Correspondent Contact OONAGH SWEENEY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/30/2005
Decision Date 11/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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