Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K902281 |
Device Name |
MODIFIED SCOOP TRANSTRACHEAL CATHETERS |
Applicant |
TRANSTRACHEAL SYSTEMS |
8755 EAST ORCHARD ROAD, |
STE.607 |
ENGLEWOOD,
CO
80111
|
|
Applicant Contact |
W PETERSON |
Correspondent |
TRANSTRACHEAL SYSTEMS |
8755 EAST ORCHARD ROAD, |
STE.607 |
ENGLEWOOD,
CO
80111
|
|
Correspondent Contact |
W PETERSON |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 05/22/1990 |
Decision Date | 08/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|