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510(k) K904681

VLS 5300 300W XENON LIGHT SOURCE by Vistek Corp. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Vistek Corp.

  • K904682 — VISTEK ELECTRONIC CONTROLLER (December 18, 1990)
  • K871034 — LCA 2000 (April 10, 1987)
  • K860173 — VIS-2000 VIDEO SYSTEM (February 7, 1986)
  • K843806 — VIS-1000 VIDEO SYSTEM (December 12, 1984)

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  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
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  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)