Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K060094 |
Device Name |
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES |
Applicant |
ARCADIA MEDICAL CORPORATION |
1450 EAST AMERICAN LANE |
SUITE 1400 |
SCHAUMBURG,
IL
60173
|
|
Applicant Contact |
MARK FOOTE |
Correspondent |
ARCADIA MEDICAL CORPORATION |
1450 EAST AMERICAN LANE |
SUITE 1400 |
SCHAUMBURG,
IL
60173
|
|
Correspondent Contact |
MARK FOOTE |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 01/12/2006 |
Decision Date | 05/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|