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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K033026
Device Name MALLARD MODEL 3000 ANESTHESIA MACHINE
Applicant
Mallard Medical, Inc.
20268 Skypark Dr.
Redding,  CA  96002
Applicant Contact ROBERT M PEARSON
Correspondent
Mallard Medical, Inc.
20268 Skypark Dr.
Redding,  CA  96002
Correspondent Contact ROBERT M PEARSON
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/26/2003
Decision Date 09/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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