The following data is part of a premarket notification filed by Best Industries with the FDA for Radioactive Samarium 145 Seeds/sources #2341-2345.
Device ID | K932242 |
510k Number | K932242 |
Device Name: | RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 |
Classification | Source, Brachytherapy, Radionuclide |
Applicant | BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
Contact | Sankara Ramaswamy |
Correspondent | Sankara 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 | 1993-05-07 |
Decision Date | 1993-07-27 |