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510(k) K191466

SandShark Injectable Anchor (SIA) System by Stimwave Technologies, Inc. — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
June 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type

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