Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K925249 |
Device Name |
CMI STOMA COVERS |
Applicant |
COMMUNITY MEDICAL CENTER |
GRAND AVE. |
P.O. BOX 8241 |
SPOKANE,
WA
99203
|
|
Applicant Contact |
BRIAN SHUTE |
Correspondent |
COMMUNITY MEDICAL CENTER |
GRAND AVE. |
P.O. BOX 8241 |
SPOKANE,
WA
99203
|
|
Correspondent Contact |
BRIAN SHUTE |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 10/16/1992 |
Decision Date | 12/03/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|