510(k) K030049 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
| Applicant | Rubicor Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Jan 29, 2003 |
| Received | Jan 6, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2006 | Rubicor Medical Rubicor EnCapsule Breast Biopsy Device, Part Number 31358,
Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.