Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K991580 |
Device Name |
ILM ENDOTRACHEAL TUBE |
Applicant |
THE LARYNGEAL MASK CO.,LTD. |
12300 TWINBROOK PKWY. |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
ROBERT L SHERIDAN |
Correspondent |
THE LARYNGEAL MASK CO.,LTD. |
12300 TWINBROOK PKWY. |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
ROBERT L SHERIDAN |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 05/07/1999 |
Decision Date | 02/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|