The following data is part of a premarket notification filed by Radiadyne with the FDA for Alatus Vaginal Balloon Packing System.
| Device ID | K092534 |
| 510k Number | K092534 |
| Device Name: | ALATUS VAGINAL BALLOON PACKING SYSTEM |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | RADIADYNE 1795 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman RADIADYNE 1795 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2009-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851546007004 | K092534 | 000 |
| 15051684018913 | K092534 | 000 |