The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Pronex.
Device ID | K102765 |
510k Number | K102765 |
Device Name: | PRONEX |
Classification | Accelerator, Linear, Medical |
Applicant | DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
Contact | Larisa Gershtein |
Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-24 |
Decision Date | 2010-12-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRONEX 98382480 not registered Live/Pending |
GLAC BIOTECH CO., LTD. 2024-01-30 |
PRONEX 90469417 not registered Live/Pending |
Nexxus Foods Inc. 2021-01-15 |
PRONEX 87228923 5525520 Live/Registered |
Promega Corporation 2016-11-07 |
PRONEX 77059377 3322565 Live/Registered |
INTERNATIONAL REHABILITATION SCIENCES, I 2006-12-07 |
PRONEX 74439884 1898764 Dead/Cancelled |
GLACIER CROSS, INC. 1993-09-24 |
PRONEX 74344283 1788014 Dead/Cancelled |
CompuTech Technologies 1992-12-30 |