K-number	K842323
Device name	AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
Applicant	American Edwards Laboratories
Product code	HRX
Device class	Class II
Decision date	Aug 17, 1984
Decision	Substantially Equivalent
Regulation	888.1100

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View the full FDA submission: accessdata.fda.gov

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AMER. EDWARDS LAB FLEXISCOPE OBTURATOR

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