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FDA 510(k) Application Details - K113232
Device Classification Name
Mixer, Breathing Gases, Anesthesia Inhalation
More FDA Info for this Device
510(K) Number
K113232
Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Applicant
MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY, UT 84107 US
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Contact
TAMMY LAVERY
Other 510(k) Applications for this Contact
Regulation Number
868.5330
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Classification Product Code
BZR
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More FDA Info for this Product Code
Date Received
11/02/2011
Decision Date
03/01/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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