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FDA 510(k) Application Details - K230732
Device Classification Name
System,X-Ray,Extraoral Source,Digital
More FDA Info for this Device
510(K) Number
K230732
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
Alliage S/A Industrias Medica Odontol≤gico.
Rod. Abrπo Assed, Km 53+450m
Recreio Anhanguera 49935 BR
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Contact
Daniel Camargo
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Regulation Number
872.1800
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Classification Product Code
MUH
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More FDA Info for this Product Code
Date Received
03/16/2023
Decision Date
04/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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