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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 K022679
Device Name RAPHAEL
Applicant
Hamilton Medical AG
P.O. Box 30008 (89520)
4990 Energy Way
Reno,  NV  89502
Applicant Contact DAVID THOMPSON
Correspondent
Hamilton Medical AG
P.O. Box 30008 (89520)
4990 Energy Way
Reno,  NV  89502
Correspondent Contact DAVID THOMPSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/12/2002
Decision Date 10/22/2003
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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