The following data is part of a premarket notification filed by Radiadyne, Llc (specification Developer) with the FDA for Radiapak Brachytherapy Applicator Balloon Device.
| Device ID | K120344 |
| 510k Number | K120344 |
| Device Name: | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | RADIADYNE, LLC (SPECIFICATION DEVELOPER) 11931 WICKCHESTER LANE Houston, TX 77043 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman RADIADYNE, LLC (SPECIFICATION DEVELOPER) 11931 WICKCHESTER LANE Houston, TX 77043 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-05-03 |
| Summary: | summary |