Device Classification Name |
syringe, antistick
|
510(k) Number |
K190183 |
Device Name |
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe |
Applicant |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
No. 2 Guanyin Road Economic Development Zone |
Taihu, Anqing City,
CN
246400
|
|
Applicant Contact |
Gang Yu |
Correspondent |
IRC |
2950 E Lindrick Drive |
Chandler,
AZ
85249
|
|
Correspondent Contact |
Charles Mack |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/01/2019 |
Decision Date | 10/04/2019 |
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
|
|
|