The following data is part of a premarket notification filed by Compagnie Oris Industrie, S.a. with the FDA for Curietron 192 Low Dose Rate.
| Device ID | K881323 |
| 510k Number | K881323 |
| Device Name: | CURIETRON 192 LOW DOSE RATE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | COMPAGNIE ORIS INDUSTRIE, S.A. BOITE POSTALE 6 F 91192 GIF-SUR-YVETTE CEDEX France, FR |
| Contact | Michael D Garrett |
| Correspondent | Michael D Garrett COMPAGNIE ORIS INDUSTRIE, S.A. BOITE POSTALE 6 F 91192 GIF-SUR-YVETTE CEDEX France, FR |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1989-01-17 |