The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Biomarc Fiducial Marker.
| Device ID | K110772 |
| 510k Number | K110772 |
| Device Name: | BIOMARC FIDUCIAL MARKER |
| Classification | Accelerator, Linear, Medical |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 -5867 |
| Contact | Andrew J Adams |
| Correspondent | Andrew J Adams CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 -5867 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10858015005575 | K110772 | 000 |
| 10858015005568 | K110772 | 000 |
| 10858015005551 | K110772 | 000 |
| 00858015005547 | K110772 | 000 |
| 10858015005537 | K110772 | 000 |
| 10858015005520 | K110772 | 000 |
| 10858015005513 | K110772 | 000 |
| 10858015005506 | K110772 | 000 |