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510(k) K100388

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS by Medical Illumination International, Inc. — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2010
Date Received
February 16, 2010
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

Other clearances by Medical Illumination International, Inc.

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  • K010495 — CENTURA PHOTOTHERAPY SPOTLIGHT (March 9, 2001)
  • K003489 — NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G (February 2, 2001)

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