510(k) K100994 ยท NEU Marker, Radiographic, Implantable
PRELOADED TISSUE MARKER DEVICE
| Applicant | Carbon Medical Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 30, 2010 |
| Received | Apr 9, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100994
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2023 | Carbon Medical Technologies, Inc. Mammotome MammoStar Biopsy Site Identified, REF STAR1401 Terminated |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.