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510(k) K082925

XENON-100 SCB LIGHT SOURCE, MODEL 20132620 by KARL STORZ Endoscopy-America, Inc. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2008
Date Received
October 1, 2008
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

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  • 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)
  • K992050 — LUMENON XENON LIGHT SOURCE (September 14, 1999)