The following data is part of a premarket notification filed by Inrad Inc. with the FDA for Easymark Tissue Marker.
| Device ID | K183503 |
| 510k Number | K183503 |
| Device Name: | EasyMark Tissue Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | INRAD Inc. 4375 Donker Court SE Kentwood, MI 49512 |
| Contact | Steve Field |
| Correspondent | Steve Field INRAD Inc. 4375 Donker Court SE Kentwood, MI 49512 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-10-17 |