The following data is part of a premarket notification filed by Wilson Instruments (sha) Co., Ltd with the FDA for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B.
| Device ID | K200769 |
| 510k Number | K200769 |
| Device Name: | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B |
| Classification | Endoscope Channel Accessory |
| Applicant | Wilson Instruments (SHA) Co., LTD Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai, CN 201702 |
| Contact | Juan Wu |
| Correspondent | Juan Wu Wilson Instruments (SHA) Co., LTD Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai, CN 201702 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2021-01-06 |