Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K161898 |
Device Name |
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set |
Applicant |
BEIJING FERT TECHNOLOGY CO., LTD |
NO.9, ZHANGGUOZHUANG VILLAGE, CHANGXINDIAN TOWN |
FENG TAI DISTRICT |
Beijing,
CN
100072
|
|
Applicant Contact |
MENG ZHANG |
Correspondent |
MID-LINK CONSULTING CO., LTD |
P.O. BOX 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/11/2016 |
Decision Date | 03/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|