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510(k) K102266

ISOLED AC-POWERED LED HEADLIGHT SYSTEM by Isolux, LLC — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2010
Date Received
August 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Fiberoptic
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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