Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K151991 |
Device Name |
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set |
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 | 07/20/2015 |
Decision Date | 12/11/2015 |
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
|
|
|