MIGUE
Accelerator, Linear, Medical
DIREX SYSTEMS CORP.
The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Migue.
Pre-market Notification Details
| Device ID | K052212 |
| 510k Number | K052212 |
| Device Name: | MIGUE |
| 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 | 2005-08-15 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
Trademark Results [MIGUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIGUE 77831380 3891921 Live/Registered |
Miguel A. Fernandez 2009-09-21 |
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