The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Re-entrant Chamber, Model 1008 Or 44d.
| Device ID | K002446 |
| 510k Number | K002446 |
| Device Name: | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Thomas L Powers |
| Correspondent | Thomas L Powers SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2000-10-23 |