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FDA 510(k) Application Details - K190894
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K190894
Device Name
Accelerator, Linear, Medical
Applicant
Essebi Medical SRL
Strada Campo del Fiume 84
Faetano 47896 SM
Other 510(k) Applications for this Company
Contact
Pietro Sordina
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2019
Decision Date
04/30/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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