The following data is part of a premarket notification filed by Worldwide Medical Technologies, Llc with the FDA for Worldwide Medical Technologies Seed Implant Needle Set.
| Device ID | K974118 |
| 510k Number | K974118 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Contact | Gary Lamoureux |
| Correspondent | Gary Lamoureux WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH Woodbury, CT 06798 -0505 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021294 | K974118 | 000 |
| 00813787021287 | K974118 | 000 |
| 00813787021270 | K974118 | 000 |
| 00813787021263 | K974118 | 000 |
| 00813787021751 | K974118 | 000 |
| 00813787021744 | K974118 | 000 |
| 00813787021737 | K974118 | 000 |