Device Classification Name |
stylet, tracheal tube
|
510(k) Number |
K162729 |
Device Name |
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY, P.O. BOX 489 |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
KOTEI AOKI |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY, P.O. BOX 489 |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
KOTEI AOKI |
Regulation Number | 868.5790
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2016 |
Decision Date | 08/11/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|