The following data is part of a premarket notification filed by Cortex Manufacturing, Inc. with the FDA for Mixed Media Marker.
| Device ID | K102506 |
| 510k Number | K102506 |
| Device Name: | MIXED MEDIA MARKER |
| Classification | Marker, Radiographic, Implantable |
| 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 | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-01 |
| Decision Date | 2011-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853730006336 | K102506 | 000 |
| 00853730006107 | K102506 | 000 |
| 00853730006114 | K102506 | 000 |
| 00853730006121 | K102506 | 000 |
| 00853730006176 | K102506 | 000 |
| 00853730006183 | K102506 | 000 |
| 00853730006190 | K102506 | 000 |
| 00853730006206 | K102506 | 000 |
| 00853730006213 | K102506 | 000 |
| 00853730006220 | K102506 | 000 |
| 00853730006237 | K102506 | 000 |
| 00853730006244 | K102506 | 000 |
| 00853730006251 | K102506 | 000 |
| 00853730006268 | K102506 | 000 |
| 00853730006091 | K102506 | 000 |