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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 and tube cuff
510(k) Number K041348
Device Name PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
Applicant
SMITHS MEDICAL
MILITARY ROAD
HYTHE, KENT,  GB CT 21 5BN
Applicant Contact BARRY SMITH
Correspondent
SMITHS MEDICAL
MILITARY ROAD
HYTHE, KENT,  GB CT 21 5BN
Correspondent Contact BARRY SMITH
Regulation Number868.5800
Classification Product Code
JOH  
Date Received05/20/2004
Decision Date 07/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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