The following data is part of a premarket notification filed by Linatech, Llc with the FDA for Tigrt Ivs.
| Device ID | K092550 |
| 510k Number | K092550 |
| Device Name: | TIGRT IVS |
| Classification | Accelerator, Linear, Medical |
| Applicant | LINATECH, LLC 1294 KIFER ROAD # 705 Sunnyvale, CA 94086 |
| Contact | Jonathan Yao |
| Correspondent | Jonathan Yao LINATECH, LLC 1294 KIFER ROAD # 705 Sunnyvale, CA 94086 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-12-15 |
| Summary: | summary |