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510(k) K133311

ENDOLED by Olympus Winter & Ibe GmbH — Product Code NTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2014
Date Received
October 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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

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