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510(k) K070331

UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES by Laborie Medical Technologies — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2007
Date Received
February 5, 2007
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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