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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 S. Cottonwood St.
Salt Lake City,  UT  84107
Applicant Contact TAMMY LAVERY
Correspondent
Maxtec, Inc.
6526 S. Cottonwood St.
Salt Lake City,  UT  84107
Correspondent Contact TAMMY LAVERY
Regulation Number868.5330
Classification Product Code
BZR  
Date Received11/02/2011
Decision Date 03/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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