K-number	K964192
Device name	ARDENT NON GAMMA-2 70
Applicant	Ardent Production Development
Product code	EJJ
Device class	Class II
Decision date	Jan 6, 1997
Decision	Substantially Equivalent
Regulation	872.3070

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View the full FDA submission: accessdata.fda.gov

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ARDENT NON GAMMA-2 70

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