FDA 510(k) Application Details - K211286

Device Classification Name Filter, Bacterial, Breathing-Circuit

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510(K) Number K211286
Device Name Filter, Bacterial, Breathing-Circuit
Applicant Pall Corporation
25 Harbor Park Drive
Port Washington, NY 11050 US
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Contact Brian Goetz
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Regulation Number 868.5260

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Classification Product Code CAH
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Date Received 04/27/2021
Decision Date 11/16/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K211286


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