Name: Predicase
Price: 199 USD

K-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
Applicant	Kobold, LLC
Product code	JAQ
Device class	Class II
Decision date	Feb 13, 2017
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.