K-number	K012156
Device name	IMAGINE H.E.
Applicant	Wieland Edelmetalle GmbH & Co.
Product code	EIH
Device class	Class II
Decision date	Aug 16, 2001
Decision	Substantially Equivalent
Regulation	872.6660

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View the full FDA submission: accessdata.fda.gov

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IMAGINE H.E.

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