The following data is part of a premarket notification filed by Imedicom Co., Ltd. with the FDA for Spinaut-p.
| Device ID | K150915 |
| 510k Number | K150915 |
| Device Name: | SPINAUT-P |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | IMEDICOM CO., LTD. #612, 172, LS-RO Gunpo-si, KR 435-824 |
| Contact | Bonggu Ha |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2016-03-18 |
| Summary: | summary |