FDA 510(k) Application Details - K001609

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K001609
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant MALLARD MEDICAL, INC.
20268 SKYPARK DR.
REDDING, CA 96002 US
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Contact ROBERT PEARSON
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 05/24/2000
Decision Date 08/10/2000
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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