The following data is part of a premarket notification filed by Best Industries with the FDA for Radioactive Palladium 103 Seeds/sources.
Device ID | K930570 |
510k Number | K930570 |
Device Name: | RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES |
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 | 1993-02-04 |
Decision Date | 1993-06-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841365112553 | K930570 | 000 |
00841365118739 | K930570 | 000 |
00841365107177 | K930570 | 000 |
00841365107184 | K930570 | 000 |
00841365107191 | K930570 | 000 |
00841365107207 | K930570 | 000 |
00841365107214 | K930570 | 000 |
00841365107221 | K930570 | 000 |
00841365107238 | K930570 | 000 |
00841365107245 | K930570 | 000 |
00841365107252 | K930570 | 000 |
00841365107269 | K930570 | 000 |
00841365107276 | K930570 | 000 |
00841365118722 | K930570 | 000 |