The following data is part of a premarket notification filed by Covidien Llc with the FDA for Beacon Fine Needle Fiducial System.
| Device ID | K152586 |
| 510k Number | K152586 |
| Device Name: | Beacon Fine Needle Fiducial System |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Covidien LLC 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Rachel Silva |
| Correspondent | Rachel Silva Covidien LLC 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2015-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855208005176 | K152586 | 000 |
| 10855208005169 | K152586 | 000 |
| 00855208005155 | K152586 | 000 |
| 00855208005148 | K152586 | 000 |