Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K200761 |
Device Name |
Tenax Laser Resistant Endotracheal Tube |
Applicant |
Bryan Medical, Inc. |
5725 Dragon Way, Suite 300 |
Cincinnati,
OH
45227
|
|
Applicant Contact |
Andrew J. Georgilis |
Correspondent |
AlvaMed, Inc. |
1116 Great Plain Avenue, Suite 1 |
Needham,
MA
02492
|
|
Correspondent Contact |
Ian Broome |
Regulation Number | 868.5730
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2020 |
Decision Date | 11/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|