The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Fine Biopsy Needle.
| Device ID | K213683 |
| 510k Number | K213683 |
| Device Name: | Promisemed Fine Biopsy Needle |
| Classification | Instrument, Biopsy |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City, CN 311121 |
| Contact | Zearou Yang |
| Correspondent | Zearou Yang Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City, CN 311121 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-04-22 |