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510(k) K220735

Avologi Gel Primer (Model: Av25) by Premier North America, Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
March 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

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