The following data is part of a premarket notification filed by Sun Nuclear Corp. with the FDA for Cal/rad Upgrade Model 1030.
| Device ID | K880272 |
| 510k Number | K880272 |
| Device Name: | CAL/RAD UPGRADE MODEL 1030 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | SUN NUCLEAR CORP. 415-C PINEDA COURT Melbourne, FL 32940 |
| Contact | William E Simon |
| Correspondent | William E Simon SUN NUCLEAR CORP. 415-C 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 | 1988-01-21 |
| Decision Date | 1988-02-29 |