The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Iridium 192 Wires & Pins.
| Device ID | K771878 |
| 510k Number | K771878 |
| Device Name: | IRIDIUM 192 WIRES & PINS |
| Classification | Source, Wire, Iridium, Radioactive |
| Applicant | CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWA |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-04 |
| Decision Date | 1977-10-27 |