K-number	K790101
Device name	ISOLATION SLEEVE, MODEL 346-01
Applicant	Intermedics, Inc.
Product code	DXY
Device class	Class III
Decision date	Jan 24, 1979
Decision	Substantially Equivalent
Regulation	870.3610

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View the full FDA submission: accessdata.fda.gov

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ISOLATION SLEEVE, MODEL 346-01

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