Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K921077 |
Device Name |
DISPOSABLE INTUBATION KITS |
Applicant |
COAST MEDICAL CORP. |
1060 NORTH BATAVIA |
UNIT H |
ORANGE,
CA
92667
|
|
Applicant Contact |
DOUGLAS R MONGEON |
Correspondent |
COAST MEDICAL CORP. |
1060 NORTH BATAVIA |
UNIT H |
ORANGE,
CA
92667
|
|
Correspondent Contact |
DOUGLAS R MONGEON |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 03/02/1992 |
Decision Date | 08/25/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|