The following data is part of a premarket notification filed by Cosman Medical, Inc. with the FDA for Fiducial Markers.
| Device ID | K101131 |
| 510k Number | K101131 |
| Device Name: | FIDUCIAL MARKERS |
| Classification | Accelerator, Linear, Medical |
| Applicant | COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 -4140 |
| Contact | Louis Falcone |
| Correspondent | Louis Falcone COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 -4140 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-06-17 |
| Summary: | summary |