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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 K101286
Device Name SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
Applicant
Linde Healthcare AB
Agavagen 54
Lidingo,  SE SE 18181
Applicant Contact ANDERS PALM
Correspondent
Linde Healthcare AB
Agavagen 54
Lidingo,  SE SE 18181
Correspondent Contact ANDERS PALM
Regulation Number868.5330
Classification Product Code
BZR  
Date Received05/07/2010
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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