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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 K083883
Device Name CHARTIS CATHETER
Applicant
Pulmonx, Inc.
24125 85th Ave. SE
Woodinville,  WA  98272
Applicant Contact Roberta Hines
Correspondent
Pulmonx, Inc.
24125 85th Ave. SE
Woodinville,  WA  98272
Correspondent Contact Roberta Hines
Regulation Number868.5740
Classification Product Code
CBI  
Date Received12/29/2008
Decision Date 06/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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