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510(k) K061690

SURGICAL HEADLIGHT by Gulf Medical Fiberoptics — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2006
Date Received
June 15, 2006
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

Other clearances by Gulf Medical Fiberoptics

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