K-number	K972057
Device name	POWERTREK INSTRUMENTS
Applicant	Medtrek Corp.
Product code	ERL
Device class	Class II
Decision date	Nov 5, 1997
Decision	Substantially Equivalent
Regulation	874.4250

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Source

View the full FDA submission: accessdata.fda.gov

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POWERTREK INSTRUMENTS

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