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 |
36945630113605 | K210745 | 000 |
36945630113612 | K210745 | 000 |
36945630113629 | K210745 | 000 |
36945630114992 | K210745 | 000 |
36945630115005 | K210745 | 000 |
36945630115012 | K210745 | 000 |
06945630125522 | K210745 | 000 |
36945630121808 | K210745 | 000 |
36945630121815 | K210745 | 000 |
06945630121821 | K210745 | 000 |
36945630124106 | K210745 | 000 |
06945630109829 | K210745 | 000 |
06945630109836 | K210745 | 000 |
36945630113599 | K210745 | 000 |