FDA 510(k) Application Details - K033405

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K033405
Device Name Generator, Oxygen, Portable
Applicant ZHEJIANG LONGFEI INDUSTRIAL CO., LTD.
2288 CAOYANG ROAD
SHANGHAI 200333 CN
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Contact COCO WANG
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 10/24/2003
Decision Date 10/18/2005
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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