The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Biopsy Breast Coil, Model Bbc.
| Device ID | K032576 |
| 510k Number | K032576 |
| Device Name: | BIOPSY BREAST COIL, MODEL BBC |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Tom Schubert |
| Correspondent | Tom Schubert 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 | 2003-08-20 |
| Decision Date | 2003-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086173 | K032576 | 000 |
| 00884838067080 | K032576 | 000 |
| 00884838066847 | K032576 | 000 |
| 00884838066779 | K032576 | 000 |
| 00884838066649 | K032576 | 000 |
| 00884838066434 | K032576 | 000 |
| 00884838066403 | K032576 | 000 |
| 00884838066335 | K032576 | 000 |
| 00884838066243 | K032576 | 000 |
| 00884838066205 | K032576 | 000 |
| 00884838066199 | K032576 | 000 |
| 00884838066182 | K032576 | 000 |
| 00884838066175 | K032576 | 000 |
| 00884838067332 | K032576 | 000 |
| 00884838067349 | K032576 | 000 |
| 00884838067356 | K032576 | 000 |
| 00884838073135 | K032576 | 000 |
| 00884838073128 | K032576 | 000 |
| 00884838073111 | K032576 | 000 |
| 00884838073104 | K032576 | 000 |
| 00884838073098 | K032576 | 000 |
| 00884838073081 | K032576 | 000 |
| 00884838073067 | K032576 | 000 |
| 00884838073043 | K032576 | 000 |
| 00884838073036 | K032576 | 000 |
| 00884838073029 | K032576 | 000 |
| 00884838073012 | K032576 | 000 |
| 00884838067363 | K032576 | 000 |
| 00884838066168 | K032576 | 000 |