Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K853051 |
Device Name |
TRACHEAL TUBES |
Applicant |
ERIE MEDICAL |
4000 SOUTH 13TH ST. |
MILWAUKEE,
WI
53221
|
|
Applicant Contact |
STEVEN A CASE |
Correspondent |
ERIE MEDICAL |
4000 SOUTH 13TH ST. |
MILWAUKEE,
WI
53221
|
|
Correspondent Contact |
STEVEN A CASE |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 07/19/1985 |
Decision Date | 04/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|