The following data is part of a premarket notification filed by Biocompatibles, Inc. with the FDA for Synthetic Seeding Spacer Model Ss9 X 50-50, Ss9 X 55-50, Ss9 X 55-150, Ss9 X 1cm-30.
| Device ID | K100847 |
| 510k Number | K100847 |
| Device Name: | SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BIOCOMPATIBLES, INC. 115 HURLEY ROAD Oxford, CT 06708 |
| Contact | Wayne W Richardson |
| Correspondent | Wayne W Richardson BIOCOMPATIBLES, INC. 115 HURLEY ROAD Oxford, CT 06708 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-05-21 |