Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K152323 |
Device Name |
Disposable Infusion Needle, Safelock Disposable Infusion Needle |
Applicant |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
NO. 2, TAIFU ROAD, HUASHI TOWN |
JIANGYIN,
CN
214421
|
|
Applicant Contact |
JUN LU |
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 | 08/17/2015 |
Decision Date | 12/14/2015 |
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
|
|
|