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FDA 510(k) Application Details - K191719
Device Classification Name
System,X-Ray,Extraoral Source,Digital
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510(K) Number
K191719
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
de Gotzen S.R.L
via Roma, 45
Olgiate Olona 21057 IT
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Contact
Dario Bandiera
Other 510(k) Applications for this Contact
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
06/26/2019
Decision Date
02/20/2020
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
N
Expedited Review
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