The following data is part of a premarket notification filed by Wilson Instruments (shanghai) Company Limited with the FDA for Disposable Endoscope Valves Set A.
| Device ID | K151714 |
| 510k Number | K151714 |
| Device Name: | Disposable Endoscope Valves Set A |
| Classification | Endoscope Channel Accessory |
| Applicant | WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BUILDING 5, NO. 258 SHUANGBANG ROAD, XUJING TOWN QINGPU DISTRICT Shanghai, CN 201702 |
| Contact | Lijuan Zhang |
| Correspondent | Lijuan Zhang WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BUILDING 5, NO. 258 SHUANGBANG ROAD, XUJING TOWN QINGPU DISTRICT 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 | 2015-06-25 |
| Decision Date | 2015-12-03 |
| Summary: | summary |