The following data is part of a premarket notification filed by Rubicor Medical, Inc. with the FDA for Rubicor Magic Breast Biopsy Device, Model 31537.
| Device ID | K071048 |
| 510k Number | K071048 |
| Device Name: | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 |
| Classification | Instrument, Biopsy |
| Applicant | RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carlos, CA 94070 |
| Contact | Robert J Chin |
| Correspondent | Robert J Chin RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carlos, CA 94070 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-13 |
| Decision Date | 2007-05-15 |
| Summary: | summary |