The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Brachysciences Strandport.
| Device ID | K062214 |
| 510k Number | K062214 |
| Device Name: | BRACHYSCIENCES STRANDPORT |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 115 HURLEY ROAD BLDG. 3B Oxford, CT 06478 |
| Contact | Wayne W Richardson |
| Correspondent | Wayne W Richardson WORLDWIDE MEDICAL TECHNOLOGIES, LLC 115 HURLEY ROAD BLDG. 3B Oxford, CT 06478 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2007-03-01 |