Name: Predicase
Price: 199 USD

K-number	K223050
Device name	AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
Applicant	MicroVention, Inc.
Product code	KRD
Device class	Class II
Decision date	Dec 21, 2022
Decision	Substantially Equivalent
Regulation	870.3300

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Source

View the full FDA submission: accessdata.fda.gov

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AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

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