The following data is part of a premarket notification filed by Rubicor Medical, Inc. with the FDA for Rubicor Breast Biopsy Device.
| Device ID | K020047 |
| 510k Number | K020047 |
| Device Name: | RUBICOR BREAST BIOPSY DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carols, CA 94070 |
| Contact | Robert J Chin |
| Correspondent | Robert J Chin RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carols, CA 94070 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-07 |
| Decision Date | 2002-04-05 |
| Summary: | summary |