FDA 510(k) Application Details - K251499

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

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510(K) Number K251499
Device Name Tube, Tracheal (W/Wo Connector)
Applicant William Cook Europe Aps
Sandet 6
Bjaeverskov 4632 DK
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Contact Mie Dyrholm
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 05/15/2025
Decision Date 06/11/2025
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

FDA Source Information for K251499


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