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510(k) K991572

ISOLUX SURGICAL HEADLIGHT by Isolux America — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1999
Date Received
May 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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