The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Locking Device.
| Device ID | K202237 |
| 510k Number | K202237 |
| Device Name: | Locking Device |
| Classification | Endoscope Channel Accessory |
| Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Contact | Yanping Fu |
| Correspondent | Yanping Fu Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2020-12-23 |