The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Readi-load System, Model Pss 1820rl.
| Device ID | K022389 |
| 510k Number | K022389 |
| Device Name: | READI-LOAD SYSTEM, MODEL PSS 1820RL |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH Woodbury, CT 06798 -0505 |
| Contact | Rick Terwilliger |
| Correspondent | Rick Terwilliger WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH 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 | 2002-07-23 |
| Decision Date | 2003-05-06 |