The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Re-entrant Chamber.
| Device ID | K013689 |
| 510k Number | K013689 |
| Device Name: | RE-ENTRANT CHAMBER |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Contact | Jim Mixon |
| Correspondent | Jim Mixon SUN NUCLEAR CORP. 425-A PINEDA COURT Melbourne, FL 32940 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-07-02 |
| Summary: | summary |