Name: Predicase
Price: 199 USD

K-number	K170622
Device name	Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
Applicant	Cook Incorporated
Product code	OQY
Device class	Class II
Decision date	Mar 31, 2017
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

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