Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K203362 |
Device Name |
TRACOE vario |
Applicant |
TRACOE medical GmbH |
Reichelsheimer Str. 1/3 |
Nieder-Olm,
DE
55268
|
|
Applicant Contact |
Katharina Schrick |
Correspondent |
Capamed Inc. |
14 E. Eau Claire Street Unit 447 |
Rice Lake,
WI
54868
|
|
Correspondent Contact |
Lu Anne Bauer |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 11/16/2020 |
Decision Date | 08/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|