K062826 is an FDA 510(k) clearance for the AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Alpha-Omega Services, Inc. (Bellflower, US). The FDA issued a Cleared decision on May 22, 2007, 244 days after receiving the submission on September 20, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K062826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2006 |
| Decision Date | May 22, 2007 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ - System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |