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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K990293
Device Name ALADDIN II MONITORING OXYGEN/AIR MONITOR
Applicant
Hamilton Medical, Inc.
3371 Lenora Church Rd.
Snellville,  GA  30039
Applicant Contact TIMOTHY Y COWART
Correspondent
Hamilton Medical, Inc.
3371 Lenora Church Rd.
Snellville,  GA  30039
Correspondent Contact TIMOTHY Y COWART
Regulation Number868.5330
Classification Product Code
BZR  
Date Received01/29/1999
Decision Date 03/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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