K940121 is an FDA 510(k) clearance for the IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS. This device is classified as a System, Applicator, Radionuclide, Manual (Class I - General Controls, product code IWJ).
Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on December 30, 1994, 354 days after receiving the submission on January 10, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5650.
| 510(k) Number | K940121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1994 |
| Decision Date | December 30, 1994 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWJ — System, Applicator, Radionuclide, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.5650 |