K991344 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on November 5, 1999, 200 days after receiving the submission on April 19, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K991344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1999 |
| Decision Date | November 05, 1999 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |