The following data is part of a premarket notification filed by Shandong Lianfa Medical Plastic Products Co. Ltd. with the FDA for Lancing System, Sterile Lancet For Single Use, Lancing Device.
| Device ID | K222472 |
| 510k Number | K222472 |
| Device Name: | Lancing System, Sterile Lancet For Single Use, Lancing Device |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Shandong Lianfa Medical Plastic Products Co. Ltd. No. 1 Shuangshan Sanjian Road, Zhangqiu Jinan, CN 250200 |
| Contact | Charles Shen |
| Correspondent | Charles Shen Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-16 |
| Decision Date | 2022-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885502007029 | K222472 | 000 |
| 00049696186773 | K222472 | 000 |
| 00049696186797 | K222472 | 000 |
| 06949517006362 | K222472 | 000 |
| 56949517070795 | K222472 | 000 |
| 56949517070801 | K222472 | 000 |
| 56949517070818 | K222472 | 000 |
| 56949517070825 | K222472 | 000 |
| 56949517070832 | K222472 | 000 |
| 56949517070849 | K222472 | 000 |
| 06949517006430 | K222472 | 000 |
| 56949517070863 | K222472 | 000 |
| 00857513006667 | K222472 | 000 |
| 56949517070870 | K222472 | 000 |