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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
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