The following data is part of a premarket notification filed by Alpha-omega Services, Inc. with the FDA for Aos Orion Ir-192 Source Cable.
| Device ID | K102811 |
| 510k Number | K102811 |
| Device Name: | AOS ORION IR-192 SOURCE CABLE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ALPHA-OMEGA SERVICES, INC. 9156 ROSE ST Bellflower, CA 90706 |
| Contact | Bob A Robnett |
| Correspondent | Bob A Robnett ALPHA-OMEGA SERVICES, INC. 9156 ROSE ST Bellflower, CA 90706 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2011-06-02 |
| Summary: | summary |