Name: Predicase
Price: 199 USD

K-number	K925588
Device name	NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
Applicant	North American Sterilization & Packaging Co.
Product code	LDQ
Device class	Class unclassified
Decision date	Dec 3, 1993
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI

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