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510(k) K031994

LINVATEC 300W XENON LIGHT SOURCE by Linvatec Corp. — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
June 27, 2003
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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Other clearances for product code GCT

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  • K013880 — DAYLITE XENON LIGHT SOURCES (December 7, 2001)
  • K992540 — XENON LIGHT SOURCE PES 1 (September 14, 1999)