Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K142144 |
Device Name |
DISPOSABLE INJECTION NEEDLE |
Applicant |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
BLDG 5, NO. 258 SHUANGBANG ROAD |
XUJING TOWN QINGPU DISTRICT |
SHANG HAI,
CN
201702
|
|
Applicant Contact |
LIJUAN ZHANG |
Correspondent |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
BLDG 5, NO. 258 SHUANGBANG ROAD |
XUJING TOWN QINGPU DISTRICT |
SHANG HAI,
CN
201702
|
|
Correspondent Contact |
LIJUAN ZHANG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/05/2014 |
Decision Date | 01/15/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|