Name: Predicase
Price: 199 USD

K-number	K053227
Device name	LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
Applicant	Medical Illumination International, Inc.
Product code	FST
Device class	Class II
Decision date	Jan 13, 2006
Decision	Substantially Equivalent
Regulation	878.4580

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Source

View the full FDA submission: accessdata.fda.gov

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LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES

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