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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K052863
Device Name RAPHAEL COLOR
Applicant
Hamilton Medical AG
Via Nova
Rhaezuens,  CH CH-7403
Applicant Contact CURDIN DANUSER
Correspondent
Hamilton Medical AG
Via Nova
Rhaezuens,  CH CH-7403
Correspondent Contact CURDIN DANUSER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/11/2005
Decision Date 01/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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