Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K862347 |
Device Name |
ENDOTRACHEAL TUBE, ACCESSORY |
Applicant |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Applicant Contact |
STEEN, PH.D. |
Correspondent |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
STEEN, PH.D. |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/20/1986 |
Decision Date | 07/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|