The following data is part of a premarket notification filed by Zhuhai Siger Medical Equipment Co., Ltd with the FDA for Dental Unit.
| Device ID | K142206 |
| 510k Number | K142206 |
| Device Name: | Dental Unit |
| Classification | Unit, Operative Dental |
| Applicant | Zhuhai Siger Medical Equipment Co., Ltd Building 2, No.1 Chuangxin Yi Road, Tangjiawan Town Zhuhai, CN 519000 |
| Contact | Huisheng Wang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-03-13 |
| Summary: | summary |