The following data is part of a premarket notification filed by Isodose Control B.v. with the FDA for Applicators For Afterloading Brachytherapy.
| Device ID | K082530 |
| 510k Number | K082530 |
| Device Name: | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede, NL 6716 Bx |
| Contact | Hub Van De Bergh |
| Correspondent | Hub Van De Bergh ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede, NL 6716 Bx |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-10-30 |
| Summary: | summary |