Device Classification Name |
container, sharps
|
510(k) Number |
K222905 |
Device Name |
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) |
Applicant |
Ningbo Maxcon Medical Technology Co., Ltd. |
No.228 Dongxin Road, Dongqiao Town |
Ningbo,
CN
315000
|
|
Applicant Contact |
Puhai Ma |
Correspondent |
Shenglin (Hangzhou) Consultants Inc. |
Room 2506, Unit 1#, Building 5#, Ronghui Business Center, |
Economic Development Zone |
Hangzhou,
CN
310018
|
|
Correspondent Contact |
Henry Zhang |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 09/23/2022 |
Decision Date | 06/01/2023 |
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
|
|
|