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 |