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510(k) K221955

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 by Realcloud Imaging Inc. Dba Realcloud Imaging — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2022
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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