The following data is part of a premarket notification filed by Dong Il Technology Ltd. with the FDA for Sonic Surgeon 310l, Sonic Surgeon 600l And Sonic Surgeon 800l.
| Device ID | K150076 |
| 510k Number | K150076 |
| Device Name: | Sonic Surgeon 310L, Sonic Surgeon 600L And Sonic Surgeon 800L |
| Classification | Drill, Bone, Powered |
| Applicant | DONG IL TECHNOLOGY LTD. 28 NAMYANG-RO 930BEON-GIL Hwaseong-si, Gyeonggi-do, KR 445-040 |
| Contact | Dong Bum Kim |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD STREET Pittsburgh, PA 15213 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-14 |
| Decision Date | 2015-06-02 |
| Summary: | summary |