The following data is part of a premarket notification filed by Dmetec Co., Ltd. with the FDA for Ultrasonic Surgery Machine.
| Device ID | K113152 |
| 510k Number | K113152 |
| Device Name: | ULTRASONIC SURGERY MACHINE |
| Classification | Drill, Bone, Powered |
| Applicant | DMETEC CO., LTD. 1415-1441 GARDENA AVE. Glendale, CA 91204 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam DMETEC CO., LTD. 1415-1441 GARDENA AVE. Glendale, CA 91204 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2012-06-14 |
| Summary: | summary |