The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Thoracic/lumbar Spine 8 Racetrack Coil, 3080-64.
| Device ID | K901241 |
| 510k Number | K901241 |
| Device Name: | THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL ADVANCES, INC. 10431 W. WATERTOWN PLANK RD. P.O. BOX 26425 Milwaukee, WI 53226 -0425 |
| Contact | William L Zabriskie |
| Correspondent | William L Zabriskie MEDICAL ADVANCES, INC. 10431 W. WATERTOWN PLANK RD. P.O. BOX 26425 Milwaukee, WI 53226 -0425 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-15 |
| Decision Date | 1990-04-25 |