The following data is part of a premarket notification filed by Viol Co., Ltd. with the FDA for Scarlet Srf.
Device ID | K180872 |
510k Number | K180872 |
Device Name: | SCARLET SRF |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Viol Co., Ltd. C-808, 809 Bundang Technopark C, 744, Pangyo-ro Bundang-gu Seongnam-si, KR 13510 |
Contact | Chai Kyoung Woo |
Correspondent | Mina Joo BT Solutions, Inc. 91-14 Seolleung-ro #402 Seoul, KR 06150 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-03 |
Decision Date | 2018-10-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809502330088 | K180872 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SCARLET SRF 87684424 5712111 Live/Registered |
Na, Jongju 2017-11-14 |