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510(k) K951971

XENON LIGHT SOURCE by Envision Medical Corp. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
April 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Envision Medical Corp.

  • K970605 — 3-CCD DIGITAL CAMERA (May 22, 1997)
  • K953438 — SURGICAL INTEGRATED CAMERA SYSTEM (November 6, 1995)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)
  • K934092 — CAMERA, SURGICAL AND ACCESSORIES (January 7, 1994)

Other clearances for product code GCT

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  • K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (December 18, 2008)
  • K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE (August 20, 2007)
  • K040949 — VIADUCT MINISCOPE AND ACCESSORIES (May 7, 2004)
  • K022490 — KSEA MEDI PACK (September 29, 2003)
  • K031994 — LINVATEC 300W XENON LIGHT SOURCE (August 21, 2003)
  • K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3 (January 14, 2003)
  • K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (August 20, 2002)
  • K020889 — ENDOSCOPIC LIGHT SOURCE XL202/L3 (June 5, 2002)
  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)