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510(k) K202822

Helianthus by Metaltronica Spa — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2021
Date Received
September 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

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