CELFIRM
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 Celfirm.
Pre-market Notification Details
| Device ID | K172023 |
| 510k Number | K172023 |
| Device Name: | CELFIRM |
| 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 | Jongju Na |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine, CA 92620 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38809502330010 | K172023 | 000 |
| 28809502330013 | K172023 | 000 |
| 08809502330040 | K172023 | 000 |
| 08809502330033 | K172023 | 000 |
| 08809502330026 | K172023 | 000 |
Trademark Results [CELFIRM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELFIRM 86921331 5054384 Live/Registered |
Viol Co. Ltd. 2016-02-26 |
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