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510(k) K190079

ArgenZ HT+ by The Argen Corporation — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
January 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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