The following data is part of a premarket notification filed by Pathfinder Therapeutics, Inc. with the FDA for Linasys.
| Device ID | K071063 |
| 510k Number | K071063 |
| Device Name: | LINASYS |
| Classification | Tracking, Soft Tissue, Intraoperative |
| Applicant | PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Contact | James D Stefansic |
| Correspondent | James D Stefansic PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Product Code | OEW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-12-20 |
| Summary: | summary |