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510(k) K243788

IceCap product line by Bioserenity Medical Devices Group — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2025
Date Received
December 9, 2024
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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