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FDA 510(k) Application Details - K101136

Device Classification Name Holding Chambers, Direct Patient Interface

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510(K) Number K101136
Device Name Holding Chambers, Direct Patient Interface
Applicant KOO(SHANGHAI)INDUSTRIES CO., LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL US
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Contact PAUL DRYDEN
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Regulation Number 868.5630

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Classification Product Code NVP
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Date Received 04/22/2010
Decision Date 01/28/2011
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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