The following data is part of a premarket notification filed by Imedicom Co., Ltd. with the FDA for Spinaut-e, Spinaut-i.
| Device ID | K150789 |
| 510k Number | K150789 |
| Device Name: | SPINAUT-E, SPINAUT-I |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | IMEDICOM CO., LTD. #612, 172, LS-ro Gunpo-si, KR 435-824 |
| Contact | Bonngu Ha |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-25 |
| Decision Date | 2016-03-01 |
| Summary: | summary |