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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 (W/Wo Connector)
510(k) Number K030792
Device Name BARD ENDOTRACHEAL TUBE, CUFFED
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact FRANCES E HARRISON
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact FRANCES E HARRISON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/12/2003
Decision Date 11/14/2003
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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