Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K133597 |
Device Name |
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY |
Applicant |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
SEAN SPENCE |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
SEAN SPENCE |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 11/22/2013 |
Decision Date | 04/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|