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510(k) K220286

ELECTROCYN soma by V3Bio Sdn. Bhd — Product Code FRO

K220286 is an FDA 510(k) premarket notification submitted by V3Bio Sdn. Bhd for the device "ELECTROCYN soma". The FDA issued a decision of Substantially Equivalent on Dec 21, 2022. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 21, 2022
Date Received
Feb 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources