FDA 510(k) Application Details - K131016

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K131016
Device Name Generator, Oxygen, Portable
Applicant MOLECULAR PRODUCTS LTD.
24301 WOODSAGE DR.
BONITA SPRINGS, FL 34134-2958 US
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Contact PAUL DRYDEN
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 04/11/2013
Decision Date 11/27/2013
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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