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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K902405
Device Name MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
Applicant
MALLINCKRODT MEDICAL
17972 SKY PARK CIR., STE A
IRVINE,  CA  92714
Applicant Contact BOB PEARSON
Correspondent
MALLINCKRODT MEDICAL
17972 SKY PARK CIR., STE A
IRVINE,  CA  92714
Correspondent Contact BOB PEARSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/31/1990
Decision Date 03/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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