FDA 510(k) Application Details - K050381

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K050381
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant CS MEDICAL INC.
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact LEWIS WARD
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 02/15/2005
Decision Date 07/13/2005
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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