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510(k) K201178

iLab Polaris Multi-Modality Guidance System by Boston Scientific — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
May 1, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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