The following data is part of a premarket notification filed by Kobold, Llc with the FDA for Kobold Fletcher-model Tandem And Ovoid Applicator Set, Kobold Henschke-model Tandem And Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set.
| Device ID | K160610 |
| 510k Number | K160610 |
| Device Name: | Kobold Fletcher-model Tandem And Ovoid Applicator Set, Kobold Henschke-model Tandem And Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | KOBOLD, LLC PO BOX 1994 Veradale, WA 99037 |
| Contact | Brian Stoddart |
| Correspondent | Christina Bernstein BB MEDICAL SURGICAL, INC. 1736 STOCKTON STREET San Francisco, CA 94133 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-03 |
| Decision Date | 2017-02-13 |
| Summary: | summary |