SCARLET SRF
Electrosurgical, Cutting & Coagulation & Accessories
Viol Co., Ltd.
The following data is part of a premarket notification filed by Viol Co., Ltd. with the FDA for Scarlet Srf.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809502330088 | K180872 | 000 |
Trademark Results [SCARLET SRF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCARLET SRF 87684424 5712111 Live/Registered |
Na, Jongju 2017-11-14 |
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