K894409 is an FDA 510(k) clearance for the CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD. This device is classified as a Source, Wire, Iridium, Radioactive (Class II - Special Controls, product code IWA).
Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on September 29, 1989, 74 days after receiving the submission on July 17, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K894409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | September 29, 1989 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWA — Source, Wire, Iridium, Radioactive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |