K-number	K860058
Device name	DENPAX
Applicant	Nissho Iwai American Corp.
Product code	EBR
Device class	Class I
Decision date	Mar 12, 1986
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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DENPAX

Everything you need for a 510(k) submission. Nothing you don't.