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510(k) K123956

POWER LED 175 by KARL STORZ Endoscopy-America, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2013
Date Received
December 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)
  • K000229 — VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (March 21, 2000)