The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Quadrature Lower Extremity Coil.
| Device ID | K934396 |
| 510k Number | K934396 |
| Device Name: | QUADRATURE LOWER EXTREMITY COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL ADVANCES, INC. 10431 W. WATERTOWN PLANK RD. P.O. BOX 26425 Milwaukee, WI 53226 -0425 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes 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 | 1993-09-09 |
| Decision Date | 1993-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838081512 | K934396 | 000 |
| 00884838065734 | K934396 | 000 |
| 00884838067011 | K934396 | 000 |
| 00884838067035 | K934396 | 000 |
| 00884838067110 | K934396 | 000 |
| 00884838067141 | K934396 | 000 |
| 00884838067271 | K934396 | 000 |
| 00884838067288 | K934396 | 000 |
| 00884838067295 | K934396 | 000 |
| 00884838067301 | K934396 | 000 |
| 00884838065727 | K934396 | 000 |