K-number	K811253
Device name	CASSETTE READER
Applicant	American Edwards Laboratories
Product code	DSH
Device class	Class II
Decision date	Jul 10, 1981
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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CASSETTE READER

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