FDA 510(k) Application Details - K181880

Device Classification Name Tube, Tracheal (W/Wo Connector)

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510(K) Number K181880
Device Name Tube, Tracheal (W/Wo Connector)
Applicant ETView Ltd.
M.P Misgav
Misgav Business Park 2017900 IL
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Contact Yoram Levy
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 07/13/2018
Decision Date 11/29/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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