The following data is part of a premarket notification filed by Rubicor Medical, Inc. with the FDA for Rubicor Magic Breast Biopsy Device.
| Device ID | K053151 |
| 510k Number | K053151 |
| Device Name: | RUBICOR MAGIC BREAST BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | RUBICOR MEDICAL, INC. 849 VETERANS BLVD. Redwood City, CA 94063 |
| Contact | Robert J Chin |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-10 |
| Decision Date | 2005-11-18 |
| Summary: | summary |