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510(k) K213170

SENSOSEEG Depth Electrodes by Sensomedical Labs, Ltd. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2023
Date Received
September 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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