FDA 510(k) Application Details - K030920

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K030920
Device Name Generator, Oxygen, Portable
Applicant ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
BUDNEY INDUSTRIAL PARK
NEWINGTON,, CT 06111 US
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Contact FRANCIS X HURSEY
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 03/24/2003
Decision Date 03/10/2004
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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