Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K193133 |
Device Name |
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set |
Applicant |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Applicant Contact |
Irasema Rivera |
Correspondent |
Cook Incorporated |
750 Daniels Way |
Bloomington,
IN
47404
|
|
Correspondent Contact |
Irasema Rivera |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 11/12/2019 |
Decision Date | 12/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|