The following data is part of a premarket notification filed by Best Industries with the FDA for Radioactive Iodine-125 Sources.
| Device ID | K912170 |
| 510k Number | K912170 |
| Device Name: | RADIOACTIVE IODINE-125 SOURCES |
| Classification | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| 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 | IWI |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365112560 | K912170 | 000 |
| 00841365106972 | K912170 | 000 |
| 00841365106989 | K912170 | 000 |
| 00841365106996 | K912170 | 000 |
| 00841365107009 | K912170 | 000 |
| 00841365107016 | K912170 | 000 |
| 00841365107023 | K912170 | 000 |
| 00841365107030 | K912170 | 000 |
| 00841365107047 | K912170 | 000 |
| 00841365107054 | K912170 | 000 |
| 00841365107061 | K912170 | 000 |
| 00841365107078 | K912170 | 000 |
| 00841365107085 | K912170 | 000 |
| 00841365112539 | K912170 | 000 |
| 00841365106965 | K912170 | 000 |