The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for `inear Wrist Coil, Model 440ge-09.
| Device ID | K991113 |
| 510k Number | K991113 |
| Device Name: | `INEAR WRIST COIL, MODEL 440GE-09 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-10 |
| Summary: | summary |