The following data is part of a premarket notification filed by North West Medical Instrument (group) Co., Ltd. with the FDA for Dental Unit With Chair.
| Device ID | K080438 |
| 510k Number | K080438 |
| Device Name: | DENTAL UNIT WITH CHAIR |
| Classification | Unit, Operative Dental |
| Applicant | NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. # 19, LANE 999 ZHONGSHAN 2 RD SUITE 8D Shanghai, CN 200030 |
| Contact | Diana Hong |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-19 |
| Decision Date | 2008-04-04 |
| Summary: | summary |