FDA 510(k) Application Details - K100920

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K100920
Device Name Generator, Oxygen, Portable
Applicant SEQUAL TECHNOLOGIES CO., LTD
6F-7, NO.136, SEC. 3
REN-AI RD
TAIPEI 10657 TW
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Contact CEARO HUANG
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 04/02/2010
Decision Date 11/29/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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