The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Liberty 9000 8-ch Breast Coil With Disposable Biopsy Plate.
| Device ID | K041695 |
| 510k Number | K041695 |
| Device Name: | LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | James Wrenn |
| Correspondent | James Wrenn USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-22 |
| Decision Date | 2004-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115827 | K041695 | 000 |
| 00840682114394 | K041695 | 000 |
| 00840682138291 | K041695 | 000 |
| 00840682138284 | K041695 | 000 |