FDA 510(k) Application Details - K080391

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K080391
Device Name Generator, Oxygen, Portable
Applicant MEDICAL DEPOT
962 ALLEGRO LANE
APOLLO BEACH, FL 33572 US
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Contact ARTHUR WARD
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 02/13/2008
Decision Date 03/18/2008
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 Y
Expedited Review



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