The following data is part of a premarket notification filed by Usa Paramed Medical Systems, Inc. with the FDA for Spine Coil.
| Device ID | K123708 |
| 510k Number | K123708 |
| Device Name: | SPINE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA PARAMED MEDICAL SYSTEMS, INC. 6204 W. OAKTON ST. Morton Grove, IL 60053 |
| Contact | Richard Olson |
| Correspondent | Richard Olson USA PARAMED MEDICAL SYSTEMS, INC. 6204 W. OAKTON ST. Morton Grove, IL 60053 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-04-10 |
| Summary: | summary |