The following data is part of a premarket notification filed by Biocompatibles, Inc. with the FDA for Worldwide Medical Technologies Anchor Marker, Marker Strand And Marker.
| Device ID | K083274 |
| 510k Number | K083274 |
| Device Name: | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BIOCOMPATIBLES, INC. 115 HURLEY ROAD Oxford, CT 06474 |
| Contact | Wayne Richardson |
| Correspondent | Wayne Richardson BIOCOMPATIBLES, INC. 115 HURLEY ROAD Oxford, CT 06474 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-06 |
| Decision Date | 2009-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021331 | K083274 | 000 |
| 00813787021126 | K083274 | 000 |
| 00813787021133 | K083274 | 000 |
| 00813787021140 | K083274 | 000 |
| 00813787021195 | K083274 | 000 |
| 00813787021201 | K083274 | 000 |
| 00813787021300 | K083274 | 000 |
| 00813787021317 | K083274 | 000 |
| 00813787021324 | K083274 | 000 |
| 00813787021119 | K083274 | 000 |