The following data is part of a premarket notification filed by Kobold, Llc with the FDA for Kobold Ring And Tandem Applicator Set.
| Device ID | K142330 |
| 510k Number | K142330 |
| Device Name: | Kobold Ring And Tandem Applicator Set |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | KOBOLD, LLC 23403 E Mission Ave, Ste 220E Liberty Lake, WA 99019 |
| Contact | Spencer Fillmore |
| Correspondent | Spencer Fillmore KOBOLD, LLC 23403 E Mission Ave, Ste 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 | 2014-08-20 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815568020069 | K142330 | 000 |
| 00815568020052 | K142330 | 000 |
| 00815568020045 | K142330 | 000 |
| 00815568020038 | K142330 | 000 |
| 00815568020960 | K142330 | 000 |
| 00815568020953 | K142330 | 000 |
| 00815568020946 | K142330 | 000 |
| 00815568020939 | K142330 | 000 |