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510(k) K151308

Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set by Schoelly Fiberoptic GmbH — Product Code FGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2016
Date Received
May 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Nephroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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