K-number	K971315
Device name	AUXILIARY INSTRUMENTS FOR URS
Applicant	Richard Wolf Medical Instruments Corp.
Product code	FCL
Device class	Class I
Decision date	Sep 15, 1997
Decision	Substantially Equivalent
Regulation	876.1075

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View the full FDA submission: accessdata.fda.gov

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AUXILIARY INSTRUMENTS FOR URS

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