K-number	K991426
Device name	MAHE INSTRUMENTS
Applicant	Mahe Intl., Inc.
Product code	FDC
Device class	Class II
Decision date	Aug 5, 1999
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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MAHE INSTRUMENTS

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