The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 675ge-64 Peripheral Vascular Coil Consisting Of Model 665ge-64: Lower Extremity Flexible Array And Model 538ge-64:.
| Device ID | K964813 |
| 510k Number | K964813 |
| Device Name: | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: |
| 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 | 1996-11-29 |
| Decision Date | 1997-02-26 |
| Summary: | summary |