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 |