K-number	K770657
Device name	GENERATOR, PULSE, CARDIAC 2LU
Applicant	Edwards Pacemaker Systems
Product code	DXY
Device class	Class III
Decision date	Apr 26, 1977
Decision	Substantially Equivalent
Regulation	870.3610

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View the full FDA submission: accessdata.fda.gov

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GENERATOR, PULSE, CARDIAC 2LU

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