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510(k) K173009

NCompass Nitinol Stone Extractors by Cook Incorporated — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2017
Date Received
September 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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