Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K222718 |
Device Name |
Vial Adapter |
Applicant |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
302,building 12, building 1,619 WangMei Road,Linping street, |
Linping DIstrict, Hangzhou |
Hangzhou,
CN
311199
|
|
Applicant Contact |
Zhengxu Xiang |
Correspondent |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
302,building 12, building 1,619 WangMei Road,Linping street, |
Linping DIstrict, Hangzhou |
Hangzhou,
CN
311199
|
|
Correspondent Contact |
Zhengxu Xiang |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/08/2022 |
Decision Date | 03/10/2023 |
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
|
|
|