The following data is part of a premarket notification filed by Suzhou Leapmed Healthcare Corporation with the FDA for Disposable Biopsy Refill Needle.
| Device ID | K212819 |
| 510k Number | K212819 |
| Device Name: | Disposable Biopsy Refill Needle |
| Classification | Biopsy Needle |
| Applicant | Suzhou Leapmed Healthcare Corporation Wuzhong Science Park, NO.2 & NO.3 Building 38# North Guandu Road, Wuzhong District Suzhou, CN 215100 |
| Contact | Yu Zhu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, CN 200120 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-07-06 |