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510(k) K122944

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR by Gemore Technology Co, Ltd. — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2012
Date Received
September 24, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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