The following data is part of a premarket notification filed by Alpha-omega Services, Inc. with the FDA for Aos Interstitial Templates, Needles & Accessories.
| Device ID | K062823 |
| 510k Number | K062823 |
| Device Name: | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| 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 | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-20 |
| Decision Date | 2007-05-29 |
| Summary: | summary |