The following data is part of a premarket notification filed by Kobold, Llc with the FDA for System, Applicator, Radionuclide, Remote Controlled.
| Device ID | K170203 |
| 510k Number | K170203 |
| Device Name: | System, Applicator, Radionuclide, Remote Controlled |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Kobold, LLC 23403 E. Mission Ave. Suite 220E Liberty Lake, WA 99019 |
| Contact | Deanna Hughes |
| Correspondent | Deanna Hughes Kobold, LLC 23403 E. Mission Ave. Suite 220E Liberty Lake, WA 99019 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815568020144 | K170203 | 000 |
| 00815568021233 | K170203 | 000 |
| 00815568021240 | K170203 | 000 |
| 00815568021257 | K170203 | 000 |
| 00815568021264 | K170203 | 000 |
| 00815568020892 | K170203 | 000 |
| 00815568020090 | K170203 | 000 |
| 00815568020106 | K170203 | 000 |
| 00815568020113 | K170203 | 000 |
| 00815568020137 | K170203 | 000 |
| 00815568021226 | K170203 | 000 |