Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K922894 |
Device Name |
LAZER-TRACH TRACHEAL TUBE |
Applicant |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Applicant Contact |
SUSAN GOLDSTEIN-FALK |
Correspondent |
SHERIDAN CATHETER CORP. |
ROUTE 40 |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
SUSAN GOLDSTEIN-FALK |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/16/1992 |
Decision Date | 05/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|