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510(k) K171430

Incontinence Treatment Device, Model LT2061 by Shenzhen Dongdixin Technology Co., Ltd. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2018
Date Received
May 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

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