The following data is part of a premarket notification filed by Biocompatibles Inc. with the FDA for Radioactive Seed Localization Needle.
| Device ID | K111979 |
| 510k Number | K111979 |
| Device Name: | RADIOACTIVE SEED LOCALIZATION NEEDLE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BIOCOMPATIBLES INC. 115 Hurley Rd Bldg 3F Oxford, CT 06478 |
| Contact | Wayne Richardson |
| Correspondent | Wayne Richardson BIOCOMPATIBLES INC. 115 Hurley Rd Bldg 3F 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 | 2011-07-12 |
| Decision Date | 2011-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787022338 | K111979 | 000 |
| 00813787022321 | K111979 | 000 |
| 00813787022314 | K111979 | 000 |
| 00813787022307 | K111979 | 000 |
| 00813787022291 | K111979 | 000 |
| 00813787022284 | K111979 | 000 |
| 00813787022277 | K111979 | 000 |
| 00813787022260 | K111979 | 000 |
| 00813787022253 | K111979 | 000 |