Name: Predicase
Price: 199 USD

K-number	K952396
Device name	REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
Applicant	Contour Fabricators of Florida, Inc.
Product code	BSY
Device class	Class I
Decision date	Aug 15, 1995
Decision	Substantially Equivalent
Regulation	868.6810

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Source

View the full FDA submission: accessdata.fda.gov

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REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION

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