The following data is part of a premarket notification filed by Radiation Safety & Nuclear Products, Inc. with the FDA for Iridium Seeds.
Device ID | K850382 |
510k Number | K850382 |
Device Name: | IRIDIUM SEEDS |
Classification | Source, Wire, Iridium, Radioactive |
Applicant | RADIATION SAFETY & NUCLEAR PRODUCTS, INC. 3641 WEST 1987 SOUTH Salt Lake City, UT 84104 |
Contact | Edd Johnson |
Correspondent | Edd Johnson RADIATION SAFETY & NUCLEAR PRODUCTS, INC. 3641 WEST 1987 SOUTH Salt Lake City, UT 84104 |
Product Code | IWA |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-01 |
Decision Date | 1985-08-15 |