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510(k) K102167

LO-50 LED LIGHT SOURCE by Fiberoptics Technology, Inc. — Product Code NTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
August 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Led Light Source
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

Other clearances by Fiberoptics Technology, Inc.

  • K904378 — F.T.I. MEDICAL LIGHT GUIDE (January 16, 1991)

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