The following data is part of a premarket notification filed by Rubicor Medical, Inc. with the FDA for Rubicor Encapsule Breast Biopsy Device, Model 31108.
| Device ID | K052506 |
| 510k Number | K052506 |
| Device Name: | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2005-10-06 |
| Summary: | summary |