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510(k) K191789

Stonetome Stone Removal Device by Boston Scientific Corporation — Product Code LQR

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 25, 2019
Date Received
July 3, 2019
Clearance Type
Special
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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