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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 K001609
Device Name MALLARD AIR OXYGEN ACCUBLENDER
Applicant
Mallard Medical, Inc.
20268 Skypark Dr.
Redding,  CA  96002
Applicant Contact ROBERT PEARSON
Correspondent
Mallard Medical, Inc.
20268 Skypark Dr.
Redding,  CA  96002
Correspondent Contact ROBERT PEARSON
Regulation Number868.5330
Classification Product Code
BZR  
Date Received05/24/2000
Decision Date 08/10/2000
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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