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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 ROAD
SUITE 400-180
INDIANAPOLIS,  IN  46236
Applicant Contact HOWARD T COOPER
Correspondent
MEDSOURCE INTERNATIONAL, LLC.
11715 FOX ROAD
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
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