K-number	K952363
Device name	OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
Applicant	Ela Medical, Inc.
Product code	ELA
Device class	Class I
Decision date	Aug 15, 1995
Decision	Substantially Equivalent
Regulation	872.4565

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OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)

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