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510(k) K182017

Compex HD by Addent, Inc. — Product Code QGO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 29, 2019
Date Received: July 27, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Composite Resin Warmer
Device Class: Class I
Regulation Number: 872.6100
Review Panel: DE
Submission Type

Intended to warm composite materials prior to use