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510(k) K241649

DUO1 and DUO2 by Zinnovi, Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2024
Date Received
June 7, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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