FDA 510(k) Application Details - K130068

Device Classification Name Unit, Liquid-Oxygen, Portable

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510(K) Number K130068
Device Name Unit, Liquid-Oxygen, Portable
Applicant ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
8007 CHIVVIS DRIVE
ST. LOUIS, MO 63123-2395 US
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Contact KEN SEISE
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Regulation Number 868.5655

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Classification Product Code BYJ
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Date Received 01/11/2013
Decision Date 07/19/2013
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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