The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Cesium 137 Source, Csm-4, Csm-11, Csm-41.
| Device ID | K852023 |
| 510k Number | K852023 |
| Device Name: | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-08 |
| Decision Date | 1985-08-21 |