Device Classification Name |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
|
510(k) Number |
K152251 |
Device Name |
Endobronchial Tube |
Applicant |
HENAN TUOREN MEDICAL DEVICE CO., LTD |
WEIYUAN INDUSTRIAL ZONE, MENGGANG, CHANGYUAN COUNTRY |
XINXIANG,
CN
453400
|
|
Applicant Contact |
MEIZI ZHANG |
Correspondent |
SHENZHEN HLONGMED BIOTECH COMPANY |
R150-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROAD, |
NANSHAN DISTRICT |
SHENZHEN,
CN
518054
|
|
Correspondent Contact |
LONG YANG |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 08/10/2015 |
Decision Date | 06/10/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|