Name: Predicase
Price: 199 USD

K-number	K170270
Device name	Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
Applicant	Ls Scientific Inc. D.B.A. Kse Scientific
Product code	FRO
Device class	Class U
Decision date	Jun 23, 2017
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

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