The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Readi-strand, Model Psstrand.
| Device ID | K023179 |
| 510k Number | K023179 |
| Device Name: | READI-STRAND, MODEL PSSTRAND |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 426 MAIN ST. NORTH Woodbury, CT 06798 -0505 |
| Contact | Gary Lamoureux |
| Correspondent | Gary Lamoureux 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 | 2002-09-24 |
| Decision Date | 2003-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021256 | K023179 | 000 |
| 00813787021249 | K023179 | 000 |
| 00813787021232 | K023179 | 000 |
| 00813787021188 | K023179 | 000 |
| 00813787021171 | K023179 | 000 |
| 00813787021164 | K023179 | 000 |
| 00813787021157 | K023179 | 000 |