The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Crystal 5000 Phases Array Tmj Coil.
| Device ID | K013528 |
| 510k Number | K013528 |
| Device Name: | CRYSTAL 5000 PHASES ARRAY TMJ COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | Rony Thomas |
| Correspondent | Rony Thomas USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2001-12-13 |
| Summary: | summary |