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510(k) K000639

VISIONARY 2000 by Burton Medical Products Corp. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2000
Date Received
February 25, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K893807 — MODEL 0183010, PEARL MEDICAL EXAM LIGHT (August 15, 1989)

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  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)