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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K111522
Device Name CHARTIS CATHETER MODEL CHR-CA-12.0
Applicant
Pulmonx, Inc.
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Applicant Contact HANS SCHULZ
Correspondent
Pulmonx, Inc.
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Correspondent Contact HANS SCHULZ
Regulation Number868.5740
Classification Product Code
CBI  
Date Received06/02/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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