K-number	K920091
Device name	IOWA ORAL PERFORMANCE ISNTRUMENT
Applicant	Breakthrough, Inc.
Product code	IKE
Device class	Class I
Decision date	May 20, 1992
Decision	Substantially Equivalent
Regulation	890.1615

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View the full FDA submission: accessdata.fda.gov

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IOWA ORAL PERFORMANCE ISNTRUMENT

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