K-number	K032395
Device name	PROPHY-MATE
Applicant	Nakanishi, Inc.
Product code	EFB
Device class	Class I
Decision date	Oct 17, 2003
Decision	Substantially Equivalent
Regulation	872.4200

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View the full FDA submission: accessdata.fda.gov

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PROPHY-MATE

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