The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Access Breast Coil.
| Device ID | K052045 |
| 510k Number | K052045 |
| Device Name: | ACCESS BREAST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | CONFIRMA, INC. 821 KIRKLAND AVE. Kirkland, WA 98033 -6318 |
| Contact | Patricia A Milbank |
| Correspondent | Patricia A Milbank CONFIRMA, INC. 821 KIRKLAND AVE. Kirkland, WA 98033 -6318 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-08-24 |
| Summary: | summary |