FDA 510(k) Application Details - K092636

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K092636
Device Name Generator, Oxygen, Portable
Applicant ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
NEWINGTON, CT 06111 US
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Contact GUY HATCH
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 08/27/2009
Decision Date 01/07/2010
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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