The following data is part of a premarket notification filed by Ningbo Medsun Medical Co., Ltd. with the FDA for Safety Lancet.
| Device ID | K222090 |
| 510k Number | K222090 |
| Device Name: | Safety Lancet |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Ningbo Medsun Medical Co., Ltd. No.55 Jinxi Road, Zhenhai Ningbo, CN 315221 |
| Contact | Liu Ping |
| Correspondent | Liu Ping Ningbo Medsun Medical Co., Ltd. No.55 Jinxi Road, Zhenhai Ningbo, CN 315221 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143550146 | K222090 | 000 |
| 16934047901611 | K222090 | 000 |