K-number	K970072
Device name	OPUS S MODEL 4121 AND 4124 PACEMAKERS
Applicant	Ela Medical, Inc.
Product code	DXY
Device class	Class III
Decision date	Aug 29, 1997
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.3610

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OPUS S MODEL 4121 AND 4124 PACEMAKERS

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