K-number	K790352
Device name	NEPHROSS 11F100
Applicant	Redy Laboratories
Product code	—
Device class	Class unclassified
Decision date	Feb 22, 1979
Decision	Substantially Equivalent — with Special Conditions
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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NEPHROSS 11F100

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