The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Biomarc Fiducial Marker.
| Device ID | K132064 |
| 510k Number | K132064 |
| Device Name: | BIOMARC 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858015005087 | K132064 | 000 |
| 10858015005056 | K132064 | 000 |
| 10850002461050 | K132064 | 000 |
| 10850002461043 | K132064 | 000 |
| 10850002461074 | K132064 | 000 |
| 10850002461067 | K132064 | 000 |
| 10850002461302 | K132064 | 000 |