FDA 510(k) Application Details - K051192

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K051192
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant PRAXAIR, INC.
175 EAST PARK DR.
2/144
TONAWANDA, NY 14150 US
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Contact TAMARA BROWN
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 05/10/2005
Decision Date 09/06/2005
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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