Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K170234 |
Device Name |
Endotracheal tube; Reinforced Endotracheal tube |
Applicant |
Zhanjiang Star Enterprise Co., Ltd |
NO.1, West Jinhua Rd. |
Zhanjiang,
TW
524094
|
|
Applicant Contact |
Rongsheng Tang |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd |
Room 1122, No.55 Shizhou Middle Road |
Nanshan District |
Shenzhen,
TW
GD755
|
|
Correspondent Contact |
Jessie You |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 01/25/2017 |
Decision Date | 01/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|