K-number	K780141
Device name	ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
Applicant	Harleco
Product code	CIJ
Device class	Class II
Decision date	Mar 9, 1978
Decision	Substantially Equivalent
Regulation	862.1070

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ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.

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