Home / 510(k) Clearances / K171366

510(k) K171366

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit by Stimwave Technologies Inc., Dba Stimq, LLC — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2017
Date Received
May 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5870
Review Panel
NE
Submission Type

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