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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 K113232
Device Name MAXMIXING BLOCK
Applicant
MAXTEC, INC.
6526 south cottonwood st.
salt lake city,  UT  84107
Contact tammy lavery
Regulation Number868.5330
Classification Product Code
BZR  
Date Received11/04/2011
Decision Date 03/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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