K063193 is an FDA 510(k) clearance for the MODIFICATION TO BIOMARC TISSUE MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Carbon Medical Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 21, 2006, 32 days after receiving the submission on October 20, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K063193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2006 |
| Decision Date | November 21, 2006 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU - Marker, Radiographic, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |