K874787 is an FDA 510(k) clearance for the MODIFIED PALLADIUM SEED MODEL 100. This device is classified as a Source, Isotope, Sealed, Gold, Titanium, Platinum (Class II - Special Controls, product code IWI).
Submitted by Theragenics Corp. (Atlanta, US). The FDA issued a Cleared decision on December 22, 1987, 29 days after receiving the submission on November 23, 1987.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K874787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1987 |
| Decision Date | December 22, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWI — Source, Isotope, Sealed, Gold, Titanium, Platinum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |