The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Irradiator For Biological Materials, Ibl-137c.
| Device ID | K865027 |
| 510k Number | K865027 |
| Device Name: | IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Malamud, Phd |
| Correspondent | Malamud, Phd CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-02-26 |