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510(k) K032430

ACUEITY MEDICAL LIGHT SOURCE by Acueity, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
August 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Acueity, Inc.

  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K032847 — EXCISOR BIOPTOME, MODEL 01-0004 (September 26, 2003)
  • K011189 — VIADUCT MICROENDOSCOPE AND ACCESSORIES (July 16, 2001)

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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)