Device Classification Name |
tube tracheostomy and tube cuff
|
510(k) Number |
K040014 |
Device Name |
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY |
Applicant |
PORTEX LTD. |
MILITARY ROAD |
HYTHE, KENT,
GB
CT21 6DB
|
|
Applicant Contact |
BARRY SMITH |
Correspondent |
PORTEX LTD. |
MILITARY ROAD |
HYTHE, KENT,
GB
CT21 6DB
|
|
Correspondent Contact |
BARRY SMITH |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 12/24/2003 |
Decision Date | 02/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|