K-number	K790491
Device name	ITIMIZED INSTRUMENTS
Applicant	E.M. Adams
Product code	FZT
Device class	Class I
Decision date	Apr 4, 1979
Decision	Substantially Equivalent
Regulation	878.4800

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Source

View the full FDA submission: accessdata.fda.gov

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ITIMIZED INSTRUMENTS

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