510(k) K200848

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit by Micron Medical Corporation — Product Code GZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2020
Date Received
March 31, 2020
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