The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Biomarc Gold Fiducial Marker.
| Device ID | K130678 |
| 510k Number | K130678 |
| Device Name: | BIOMARC GOLD FIDUCIAL MARKER |
| Classification | Accelerator, Linear, Medical |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd Saint Paul, MN 55110 |
| Contact | Andrew J Adams |
| Correspondent | Andrew J Adams CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd Saint Paul, MN 55110 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858015005193 | K130678 | 000 |
| 10858015005155 | K130678 | 000 |
| 10858015005131 | K130678 | 000 |
| 10858015005070 | K130678 | 000 |