K042296 is an FDA 510(k) clearance for the BIOMARC PRELOADED TISSUE MARKER DEVICE. 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 September 20, 2004, 27 days after receiving the submission on August 24, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K042296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2004 |
| Decision Date | September 20, 2004 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| 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 |