The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Safety Lancet (xiii, Xvii, Xxi, Xxii, Xxiii, Xxiv, Xxv, Xxvi).
| Device ID | K220370 |
| 510k Number | K220370 |
| Device Name: | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, CN 300308 |
| Contact | Yuan Ying |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza,West Guangzhong Road 555, Jingan District Shanghai, CN 200072 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-09 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80816042013535 | K220370 | 000 |
| 80816042013542 | K220370 | 000 |