Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K083031 |
Device Name |
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT |
Applicant |
SMITHS MEDICAL ASD, INC. |
BOUNDARY ROAD |
HYTHE, KENT,
GB
CT216JN
|
|
Applicant Contact |
JOHN TULLETT |
Correspondent |
SMITHS MEDICAL ASD, INC. |
BOUNDARY ROAD |
HYTHE, KENT,
GB
CT216JN
|
|
Correspondent Contact |
JOHN TULLETT |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 10/10/2008 |
Decision Date | 08/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|