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510(k) K992540

XENON LIGHT SOURCE PES 1 by Laser Optik Systeme GmbH & Co. KG — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1999
Date Received
July 29, 1999
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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