The following data is part of a premarket notification filed by Xianyang North West Medical Instrument (group) Co. with the FDA for Dental Unit With Chair.
| Device ID | K130410 |
| 510k Number | K130410 |
| Device Name: | DENTAL UNIT WITH CHAIR |
| Classification | Unit, Operative Dental |
| Applicant | XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-07-26 |
| Summary: | summary |