GENETRA
Source, Brachytherapy, Radionuclide
RADIOMED CORPORATION
The following data is part of a premarket notification filed by Radiomed Corporation with the FDA for Genetra.
Pre-market Notification Details
| Device ID | K013660 |
| 510k Number | K013660 |
| Device Name: | GENETRA |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400 |
| Contact | Gordon Roberts |
| Correspondent | Gordon Roberts RADIOMED CORPORATION ONE INDUSTRIAL WAY Tyngsboro, MA 01879 -1400 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2001-12-05 |
| Summary: | summary |
Trademark Results [GENETRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENETRA 76306825 not registered Dead/Abandoned |
Kawasumi Kagaku Kogyo Kabushikl-Kaisha 2001-08-30 |
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