Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K170720 |
Device Name |
Portex Blue Line Ultra Paediatric Tracheosomy Tube |
Applicant |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Applicant Contact |
James Taufen |
Correspondent |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Correspondent Contact |
James Taufen |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 03/09/2017 |
Decision Date | 12/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|