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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 K861432
Device Name VEOLAR VENTILATOR
Applicant
Hamilton Medical, Inc.
P.O. Box 30008
Reno,  NV  89520
Applicant Contact ERIC GJERDE
Correspondent
Hamilton Medical, Inc.
P.O. Box 30008
Reno,  NV  89520
Correspondent Contact ERIC GJERDE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/16/1986
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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