The following data is part of a premarket notification filed by Alpha-omega Services, Inc. with the FDA for Aos Universal Connecting Guide Tube For High Dose Rate Afterloaders.
| Device ID | K964910 |
| 510k Number | K964910 |
| Device Name: | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | ALPHA-OMEGA SERVICES, INC. 9156 ROSE ST. Bellflower, CA 90706 |
| Contact | Cary Hedger |
| Correspondent | Cary Hedger 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 | 1996-12-09 |
| Decision Date | 1997-03-10 |
| Summary: | summary |