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 Number | 868.5800
|
Classification Product Code |
|
Date Received | 05/20/2004 |
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
|
|
|