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— 510(k) K160610

Name: FDA 510(k) clearance K160610
Creator: U.S. Food and Drug Administration
Published: 2017-02-13

Substantially Equivalent

Kobold, LLC

FDA 510(k) clearance K160610 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, Substantially Equivalent on 2017-02-13. Applicant: Kobold, LLC. Device class: 2.

Clearance details

Applicant: Kobold, LLC
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2016-03-03
Decision date: 2017-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veradale, WA, US

Download summary PDF View on FDA.gov ↗

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