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510(k) K163448

GrindCare System by Sunstar Suisse S.A. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2017
Date Received
December 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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