Device Classification Name |
Airway, Esophageal (Obturator)
|
510(k) Number |
K875226 |
Device Name |
ESOPHAGEAL OBTURATOR/TRACHEAL TUBE |
Applicant |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Applicant Contact |
JOHN STEEN |
Correspondent |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
JOHN STEEN |
Regulation Number | 868.5650
|
Classification Product Code |
|
Date Received | 12/22/1987 |
Decision Date | 01/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|