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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 K982910
Device Name HAMILTON MEDICAL GALILEOVENTILATOR
Applicant
Hamilton Medical, Inc.
505 Edison Way
P.O. Box 30008
Reno,  NV  89520
Applicant Contact J. DAVID THOMPSON
Correspondent
Hamilton Medical, Inc.
505 Edison Way
P.O. Box 30008
Reno,  NV  89520
Correspondent Contact J. DAVID THOMPSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/18/1998
Decision Date 09/14/1999
Decision SE SUBJECT TO TRACKING REG (ST)
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
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