The following data is part of a premarket notification filed by Kent Medical Devices, Inc. with the FDA for Kmd-mark1 Tissue Marker.
| Device ID | K093473 |
| 510k Number | K093473 |
| Device Name: | KMD-MARK1 TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | KENT MEDICAL DEVICES, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton KENT MEDICAL DEVICES, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-11-06 |
| Decision Date | 2010-07-02 |
| Summary: | summary |