The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Virtuerf.
Device ID | K202415 |
510k Number | K202415 |
Device Name: | VirtueRF |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul, KR 04796 |
Contact | Oskar Lee |
Correspondent | Connie Hoy Hoy And Associates 3916 N. Potsdam Ave #4676 Sioux Falls, SD 57104 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-24 |
Decision Date | 2021-01-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800017100456 | K202415 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIRTUERF 88756733 not registered Live/Pending |
SHENB CO., LTD. 2020-01-13 |