The following data is part of a premarket notification filed by Best Industries with the FDA for Radioactive Cesium-131 Seeds/sources.
Device ID | K924261 |
510k Number | K924261 |
Device Name: | RADIOACTIVE CESIUM-131 SEEDS/SOURCES |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
Contact | Sankara I Ramaswamy |
Correspondent | Sankara I Ramaswamy BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
Product Code | KXK |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-06-04 |