The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Cesium 137 Source, Model Csm-40.
| Device ID | K882449 |
| 510k Number | K882449 |
| Device Name: | CESIUM 137 SOURCE, MODEL CSM-40 |
| Classification | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| Applicant | CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Contact | Rita T Mccullough |
| Correspondent | Rita T Mccullough CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Product Code | IWI |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1989-04-14 |