The following data is part of a premarket notification filed by Civco with the FDA for Fiducial Markers.
| Device ID | K071614 |
| 510k Number | K071614 |
| Device Name: | FIDUCIAL MARKERS |
| Classification | Accelerator, Linear, Medical |
| Applicant | CIVCO 1401 8TH ST. SE Orange City, IA 51041 -0320 |
| Contact | Jim Leong |
| Correspondent | Jim Leong CIVCO 1401 8TH ST. SE Orange City, IA 51041 -0320 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-13 |
| Decision Date | 2007-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439109762 | K071614 | 000 |
| 00841439109717 | K071614 | 000 |
| 00841439109700 | K071614 | 000 |
| 00841439109694 | K071614 | 000 |
| 00841439109687 | K071614 | 000 |
| 00841439109670 | K071614 | 000 |
| 00841439109663 | K071614 | 000 |
| 00841439109656 | K071614 | 000 |
| 00841439109649 | K071614 | 000 |
| 00841439109632 | K071614 | 000 |
| 00841439109625 | K071614 | 000 |
| 00841439109618 | K071614 | 000 |
| 00841439109601 | K071614 | 000 |
| 00841439109595 | K071614 | 000 |
| 00841439109588 | K071614 | 000 |
| 00841439109724 | K071614 | 000 |
| 00841439109731 | K071614 | 000 |
| 00841439109892 | K071614 | 000 |
| 00841439109885 | K071614 | 000 |
| 00841439109878 | K071614 | 000 |
| 00841439109861 | K071614 | 000 |
| 00841439109854 | K071614 | 000 |
| 00841439109847 | K071614 | 000 |
| 00841439109830 | K071614 | 000 |
| 00841439109816 | K071614 | 000 |
| 00841439109809 | K071614 | 000 |
| 00841439109793 | K071614 | 000 |
| 00841439109786 | K071614 | 000 |
| 00841439109779 | K071614 | 000 |
| 00841439109755 | K071614 | 000 |
| 00841439109748 | K071614 | 000 |
| 00841439109571 | K071614 | 000 |