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510(k) K151191

OES ELITE Telescopes, Protective Tube by Olympus Winter & Ibe GmbH — Product Code FBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2015
Date Received
May 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Rigid, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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