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510(k) K053227

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES by Medical Illumination International, Inc. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
November 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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