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510(k) K081477

LUXTEC MLX LIGHT SOURCE by Integra Luxtec, Inc. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2008
Date Received
May 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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