Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K161813 |
Device Name |
Frova Intubating Introducer |
Applicant |
WILLIAM COOK EUROPE APS |
SANDET 6 |
BJAEVERSKOV,
DK
4632
|
|
Applicant Contact |
Henriette Stordal Christiansen |
Correspondent |
WILLIAM COOK EUROPE APS |
SANDET 6 |
BJAEVERSKOV,
DK
4632
|
|
Correspondent Contact |
Henriette Stordal Christiansen |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 07/01/2016 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|