Radiadyne, LLC (Specification Developer) · Class II · Cleared May 3, 2012
| K-number | K120344 |
| Device name | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE |
| Applicant | Radiadyne, LLC (Specification Developer) |
| Product code | JAQ |
| Device class | Class II |
| Decision date | May 3, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 892.5700 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov