The following data is part of a premarket notification filed by Lccs Products Limited with the FDA for Lccs Vc-s Rf Cannula.
Device ID | K191293 |
510k Number | K191293 |
Device Name: | LCCS VC-S RF Cannula |
Classification | Probe, Radiofrequency Lesion |
Applicant | LCCS Products Limited Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai Ying Pun Hong Kong, CN |
Contact | Nick Xu |
Correspondent | Nick Xu LCCS Products Limited Office 3a-7, 12/F, Kaiser Center, No.18 Center Street, Sai Ying Pun Hong Kong, CN |
Product Code | GXI |
CFR Regulation Number | 882.4725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-14 |
Decision Date | 2020-01-24 |
Summary: | summary |