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510(k) K153019

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes by Bio Protech, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2016
Date Received
October 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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