The following data is part of a premarket notification filed by Imedicom Co., Ltd. with the FDA for Epinaut.
| Device ID | K173541 |
| 510k Number | K173541 |
| Device Name: | EPINAUT |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | Imedicom Co., Ltd. #612, 172, LS-ro Gunpo-si, KR 435824 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine, CA 92620 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-15 |
| Decision Date | 2018-08-24 |
| Summary: | summary |