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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 K060945
Device Name PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
Applicant
SMITHS MEDICAL INTERNATIONAL
1 ST. CRISPIN WAY
HASLINGDEN
ROSSENDALE, LANCASHIRE,  GB BB4 4PW
Applicant Contact STEWART LEE
Correspondent
SMITHS MEDICAL INTERNATIONAL
1 ST. CRISPIN WAY
HASLINGDEN
ROSSENDALE, LANCASHIRE,  GB BB4 4PW
Correspondent Contact STEWART LEE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received04/06/2006
Decision Date 06/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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