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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 K080339
Device Name MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
Applicant
Medsource International, LLC
11715 Fox Rd. Suite 400-180
Indianapolis,  IN  46236
Applicant Contact HOWARD T COOPER
Correspondent
Medsource International, LLC
11715 Fox Rd. Suite 400-180
Indianapolis,  IN  46236
Correspondent Contact HOWARD T COOPER
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/08/2008
Decision Date 10/27/2008
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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