The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Biomarc Fiducial Marker.
| Device ID | K132708 |
| 510k Number | K132708 |
| Device Name: | BIOMARC FIDUCIAL MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Andrew J Adams |
| Correspondent | Andrew J Adams CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858015005042 | K132708 | 000 |
| 00858015005035 | K132708 | 000 |
| 00858015005028 | K132708 | 000 |