The following data is part of a premarket notification filed by Cortex Manufacturing, Inc. with the FDA for Fleximarc, Model Cm-0.9-2-10-gg-l.
| Device ID | K100267 |
| 510k Number | K100267 |
| Device Name: | FLEXIMARC, MODEL CM-0.9-2-10-GG-L |
| Classification | Accelerator, Linear, Medical |
| Applicant | CORTEX MANUFACTURING, INC. 421 S. DAVIES RD. Lake Stevens, WA 98258 |
| Contact | Andrew Jones |
| Correspondent | Andrew Jones CORTEX MANUFACTURING, INC. 421 S. DAVIES RD. Lake Stevens, WA 98258 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-29 |
| Decision Date | 2010-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853730006329 | K100267 | 000 |
| 00853730006015 | K100267 | 000 |
| 00853730006022 | K100267 | 000 |
| 00853730006039 | K100267 | 000 |
| 00853730006046 | K100267 | 000 |
| 00853730006053 | K100267 | 000 |
| 00853730006060 | K100267 | 000 |
| 00853730006077 | K100267 | 000 |
| 00853730006084 | K100267 | 000 |
| 00853730006138 | K100267 | 000 |
| 00853730006145 | K100267 | 000 |
| 00853730006152 | K100267 | 000 |
| 00853730006169 | K100267 | 000 |
| 00853730006275 | K100267 | 000 |
| 00853730006282 | K100267 | 000 |
| 00853730006299 | K100267 | 000 |
| 00853730006305 | K100267 | 000 |
| 00853730006312 | K100267 | 000 |
| 00853730006008 | K100267 | 000 |