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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
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