The following data is part of a premarket notification filed by Linatech, Llc with the FDA for Tigrt Mlc, Tigrt Dmlc.
Device ID | K090802 |
510k Number | K090802 |
Device Name: | TIGRT MLC, TIGRT DMLC |
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 | 2009-03-24 |
Decision Date | 2009-07-07 |
Summary: | summary |