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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 K080170
Device Name AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact SKIP RIMER
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact SKIP RIMER
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/24/2008
Decision Date 03/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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