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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 K081086
Device Name PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
Applicant
SMITHS MEDICAL ASD, INC.
MILITARY ROAD
HYTHE, KENT,  GB CT216JL
Applicant Contact JOHN TULLETT
Correspondent
SMITHS MEDICAL ASD, INC.
MILITARY ROAD
HYTHE, KENT,  GB CT216JL
Correspondent Contact JOHN TULLETT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/16/2008
Decision Date 08/13/2008
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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