The following data is part of a premarket notification filed by Shanghai Foshion Medical Instruments Co., Ltd. with the FDA for Foshion Chair Mounted Dental, Model Fj48c.
| Device ID | K071353 |
| 510k Number | K071353 |
| Device Name: | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. 342 E MAIN ST, SUITE 211 NO.3 RD Leola, PA 17540 |
| Contact | William Mclain |
| Correspondent | William Mclain SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. 342 E MAIN ST, SUITE 211 NO.3 RD Leola, PA 17540 |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-15 |
| Decision Date | 2007-12-14 |
| Summary: | summary |