Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K900236 |
Device Name |
ET-RESTRAINT CAT. # ER 4000 |
Applicant |
VENTLAB CORP. |
221 GRACIE PLACE |
HACKENSACK,
NJ
07601
|
|
Applicant Contact |
GREGORY LAU |
Correspondent |
VENTLAB CORP. |
221 GRACIE PLACE |
HACKENSACK,
NJ
07601
|
|
Correspondent Contact |
GREGORY LAU |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 01/17/1990 |
Decision Date | 02/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|