The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Heel Incision Safety Lancet.
| Device ID | K210745 |
| 510k Number | K210745 |
| Device Name: | Heel Incision Safety Lancet |
| Classification | Lancet, Blood |
| Applicant | SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou, CN 215153 |
| Contact | Yuan Jie |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-12 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945630109843 | K210745 | 000 |
| 06945630109836 | K210745 | 000 |
| 06945630109829 | K210745 | 000 |
| 36945630124106 | K210745 | 000 |
| 06945630121821 | K210745 | 000 |
| 36945630121815 | K210745 | 000 |
| 36945630121808 | K210745 | 000 |
| 06945630125522 | K210745 | 000 |