Name: Predicase
Price: 199 USD

K-number	K182146
Device name	Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
Applicant	Sol-Millennium Medical, Inc.
Product code	FMI
Device class	Class II
Decision date	Dec 3, 2018
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

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