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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K030570
Device Name BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Applicant
PORTEX LTD.
MILITARY ROAD
HYTH, KENT,  GB CT21 6DB
Applicant Contact STEVE OGILVIE
Correspondent
PORTEX LTD.
MILITARY ROAD
HYTH, KENT,  GB CT21 6DB
Correspondent Contact STEVE OGILVIE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/24/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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