FDA 510(k) Application Details - K080023

Device Classification Name Unit, Liquid-Oxygen, Portable

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510(K) Number K080023
Device Name Unit, Liquid-Oxygen, Portable
Applicant CAIRE, INC.
1800 SANDY PLAINS INDUSTRIAL
PARKWAY, STE.316
MARIETTA, GA 30066 US
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Contact ZULFIQAR A CHOUDARY
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Regulation Number 868.5655

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Classification Product Code BYJ
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Date Received 01/04/2008
Decision Date 06/16/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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