The following data is part of a premarket notification filed by Shanghai Dental Instrument Factory with the FDA for Sdif Dental Chair With Operative Unit And Accessories.
| Device ID | K063302 |
| 510k Number | K063302 |
| Device Name: | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES |
| Classification | Unit, Operative Dental |
| Applicant | SHANGHAI DENTAL INSTRUMENT FACTORY REGULATORY TECHNOLOGY SERVICES 1394 25TH STREET, NW Buffalo, MN 55313 |
| Contact | Mark Job |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2006-11-15 |
| Summary: | summary |