K-number	K850478
Device name	PLUS 1
Applicant	Dymax Corp
Product code	IYO
Device class	Class II
Decision date	Apr 15, 1985
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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PLUS 1

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