The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Model Bbc-127 Biopsy Breast Coil.
| Device ID | K041481 |
| 510k Number | K041481 |
| Device Name: | MODEL BBC-127 BIOPSY BREAST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-03 |
| Decision Date | 2004-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838066540 | K041481 | 000 |
| 00884838065413 | K041481 | 000 |
| 00884838065406 | K041481 | 000 |