The following data is part of a premarket notification filed by Dong Il Technology Ltd. with the FDA for Ultrasonic Surgical Unit.
| Device ID | K110881 |
| 510k Number | K110881 |
| Device Name: | ULTRASONIC SURGICAL UNIT |
| Classification | Drill, Bone, Powered |
| Applicant | DONG IL TECHNOLOGY LTD. 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung DONG IL TECHNOLOGY LTD. 300 ATWOOD 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 | 2011-03-30 |
| Decision Date | 2011-12-16 |
| Summary: | summary |