The following data is part of a premarket notification filed by Wilson Instruments (shanghai) Company Limited with the FDA for Disposable Injection Needle.
| Device ID | K142144 |
| 510k Number | K142144 |
| Device Name: | DISPOSABLE INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BLDG 5, NO. 258 SHUANGBANG ROAD XUJING TOWN QINGPU DISTRICT Shang Hai, CN 201702 |
| Contact | Lijuan Zhang |
| Correspondent | Lijuan Zhang WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BLDG 5, NO. 258 SHUANGBANG ROAD XUJING TOWN QINGPU DISTRICT Shang Hai, CN 201702 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2015-01-15 |
| Summary: | summary |