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FDA 510(k) Application Details - K101286
Device Classification Name
Mixer, Breathing Gases, Anesthesia Inhalation
More FDA Info for this Device
510(K) Number
K101286
Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Applicant
LINDE HEALTHCARE AB
AGAVAGEN 54
LIDINGO SE 18181 SE
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Contact
ANDERS PALM
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
05/07/2010
Decision Date
10/20/2011
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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