K-number	K842410
Device name	AMER. EDWARDS LAB FLEXISCOPE
Applicant	American Edwards Laboratories
Product code	HRK
Device class	Class I
Decision date	Nov 5, 1984
Decision	Substantially Equivalent
Regulation	886.4855

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View the full FDA submission: accessdata.fda.gov

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AMER. EDWARDS LAB FLEXISCOPE

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