FDA 510(k) Application Details - K060922

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K060922
Device Name Generator, Oxygen, Portable
Applicant OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE, NC 28792 US
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Contact MARGARET K POTEAT
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 04/04/2006
Decision Date 05/30/2006
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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