The following data is part of a premarket notification filed by Cortex Manufacturing, Inc. with the FDA for Fleximarc Marker.
| Device ID | K142294 |
| 510k Number | K142294 |
| Device Name: | FlexiMarc Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | CORTEX MANUFACTURING, INC. 421 South Davies Rd. Lake Stevens, WA 98258 |
| Contact | Andrew Jones |
| Correspondent | Andrew Jones CORTEX MANUFACTURING, INC. 421 South Davies Rd. Lake Stevens, WA 98258 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-18 |
| Decision Date | 2015-03-26 |
| Summary: | summary |