The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies Seeding Spacers.
| Device ID | K991344 |
| 510k Number | K991344 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Contact | Gary A Lamoureux |
| Correspondent | Gary A Lamoureux WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-11-05 |