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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 K022212
Device Name PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
Applicant
MENTOR MEDICAL LIMITED
MILITARY ROAD
HYTHE, KENT,  GB CT21 6DB
Applicant Contact STEVE OGILVIE
Correspondent
MENTOR MEDICAL LIMITED
MILITARY ROAD
HYTHE, KENT,  GB CT21 6DB
Correspondent Contact STEVE OGILVIE
Regulation Number868.5800
Classification Product Code
JOH  
Date Received07/08/2002
Decision Date 03/21/2003
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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