The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Blood Lancet, Verifine Safety Lancet, Verifine Mini-safety Lancet.
| Device ID | K221368 |
| 510k Number | K221368 |
| Device Name: | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City, CN 311121 |
| Contact | Zearou Yang |
| Correspondent | Wei Shan Hsu Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, HK |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-12 |
| Decision Date | 2022-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850011833732 | K221368 | 000 |
| 80850011833601 | K221368 | 000 |
| 10850011833534 | K221368 | 000 |
| 10850011833503 | K221368 | 000 |
| 10850011833442 | K221368 | 000 |
| 10850011833237 | K221368 | 000 |
| 10850011833206 | K221368 | 000 |
| 10850011833138 | K221368 | 000 |